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Greenlight Guru QMS

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

Get a personalized demo of SMART-TRIAL by Greenlight Guru today.

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Greenlight Guru Academy

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

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The Global Medical Device Podcast

The GMDP is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Global Medical Device Podcast

How AI Can Help You Manage Risk

Episode 319

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Global Medical Device Podcast

The Tools that Make Clinical Investigations

Episode 318

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Global Medical Device Podcast

Complaint Handling with Medical Device Guru, Brittney McIver

Episode 317

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Global Medical Device Podcast

Avoiding Potential Issues with your 510(k) Submission

Episode 316

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Global Medical Device Podcast

Meet a Guru: Brittani Smith

Episode 315

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Global Medical Device Podcast

Why Building Supplier Relationships Is So Important

Episode 314

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Global Medical Device Podcast

Systematic Literature Review for EU MDR

Episode 313

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Global Medical Device Podcast

Building Your Design Controls (and Pitfalls to Avoid)

Episode 312

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Global Medical Device Podcast

Most Common Problems Found During FDA Inspections in 2022

Episode 311

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Global Medical Device Podcast

V&V Activities from a Verification Engineer POV - How Hard Could It Be?

Episode 310

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Global Medical Device Podcast

Understanding the 'Compliance Manager' Role

Episode 309

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Global Medical Device Podcast

DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact

Episode 308

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Global Medical Device Podcast

How Communication Affects the Outcomes of Quality Activities

Episode 307

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Global Medical Device Podcast

Part 2: The Theranos Loophole & Lab Developed Tests

Episode 306

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Global Medical Device Podcast

Part 1: The Theranos Loophole & Lab Developed Tests

Episode 305

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Global Medical Device Podcast

Implementing an eQMS after Switching from Paper

Episode 304

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Global Medical Device Podcast

Essentials of Sterilization for Med Device Professionals

Episode 303

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Global Medical Device Podcast

UDI: 101

Episode 302

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Global Medical Device Podcast

Quality Myths and Lessons Learned

Episode 301

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Global Medical Device Podcast

Determining User Needs for Your Medical Device

Episode 300

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Global Medical Device Podcast

Fraud in the Healthcare Industry & the Role of Whistleblowers

Episode 299

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Global Medical Device Podcast

Auditing the Auditor

Episode 298

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Global Medical Device Podcast

What is MedTech Lifecycle Excellence?

Episode 297

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Global Medical Device Podcast

The Best of Jon & Mike Through the Years

Episode 296

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Global Medical Device Podcast

CDRH Proposed Guidance for FY 2023

Episode 295

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Global Medical Device Podcast

Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond

Episode 294

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Global Medical Device Podcast

The Future of Healthcare & How We Get There

Episode 293

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Global Medical Device Podcast

What "Exempt" Means with Respect to Medical Devices & Regulatory

Episode 292

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Global Medical Device Podcast

Developing a Regulatory Strategy

Episode 291

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Global Medical Device Podcast

We Achieved ISO Certification! Now what?

Episode 290

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Global Medical Device Podcast

The Future of Reprocessed Used Medical Equipment

Episode 289

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Global Medical Device Podcast

The Importance of Cervical Cancer Screening in the U.S.

Episode 288

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Global Medical Device Podcast

Customer Discovery for Medical Device Companies

Episode 287

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Global Medical Device Podcast

EUA and the Impending Transition

Episode 286

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Global Medical Device Podcast

Common QMS Mistakes SaMD Companies Make

Episode 285

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Global Medical Device Podcast

Design Assurance: The Unsung Heroes of R&D

Episode 284

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Global Medical Device Podcast

Lessons from an Industry Leader: Playing the Long Game of MedTech

Episode 283

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Global Medical Device Podcast

7 Common 510(k) Mistakes and How to Avoid Them

Episode 282

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Global Medical Device Podcast

Best Practices for Clinical Evidence Management

Episode 281

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Global Medical Device Podcast

Building Your Regulatory Strategy for Commercialization

Episode 280

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Global Medical Device Podcast

Packaging Validation Best Practices

Episode 279

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Global Medical Device Podcast

Overcoming Submission Deficiencies due to Biocompatibility

Episode 278

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Global Medical Device Podcast

Does Your CAPA Process Need a CAPA?

Episode 277

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Global Medical Device Podcast

UDI and the Current State of Global Implementation

Episode 276

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Global Medical Device Podcast

The Changing Job Market & How it Affects Careers for MedTech Quality Professionals

Episode 275

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Global Medical Device Podcast

Digitizing your SaMD Testing

Episode 274

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Global Medical Device Podcast

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

Episode 273

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Global Medical Device Podcast

Guerilla Tactics for Quality Leadership

Episode 272

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Global Medical Device Podcast

Preventing the Death of Medical Device Sales

Episode 271

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Global Medical Device Podcast

Shifting Sands of SaMD Cybersecurity Regulations

Episode 270

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Global Medical Device Podcast

Early Stage Territory Planning for Medical Device Companies

Episode 269

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Global Medical Device Podcast

Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry

Episode 268

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Global Medical Device Podcast

What Impact Does a QMS & Regulatory Have on Fundraising and Pre-money Valuation?

Episode 267

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Global Medical Device Podcast

Early Feasibility Studies in Latin America

Episode 266

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Global Medical Device Podcast

Software Bill of Materials (SBOMs) & Cybersecurity in the Medical Device Industry

Episode 265

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Global Medical Device Podcast

Approaching Cybersecurity & Usability as a SaMD Company

Episode 264

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Global Medical Device Podcast

The Future of Lateral Flow Test Technology

Episode 263

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Global Medical Device Podcast

Building a Culture of Quality

Episode 262

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Global Medical Device Podcast

Bringing Medical Devices Into The Home

Episode 261

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Global Medical Device Podcast

Demystifying the De Novo Process

Episode 260

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Global Medical Device Podcast

Challenges for Regulatory Submission: EU vs. US

Episode 259

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Global Medical Device Podcast

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

Episode 258

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Global Medical Device Podcast

The Future of Cybersecurity

Episode 257

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Global Medical Device Podcast

Achieving Operational Readiness through Good Project Management

Episode 256

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Global Medical Device Podcast

Bridging the Gap between Medical Devices and Clinical Data

Episode 255

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Global Medical Device Podcast

Navigating the Medical Device Single Audit Program (MDSAP)

Episode 254

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Global Medical Device Podcast

Bringing Augmented Reality MedTech to Market

Episode 253

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Global Medical Device Podcast

Making Your Informational Meetings With FDA Valuable & Worthwhile

Episode 252

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Global Medical Device Podcast

Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs

Episode 251

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Global Medical Device Podcast

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

Episode 250

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Global Medical Device Podcast

How Medical Device Intellectual Property Protection Varies by Sector

Episode 249

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Global Medical Device Podcast

Human Factors & Risk Management: What's Needed & Why?

Episode 248

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Global Medical Device Podcast

What are the Opportunities for Improvement (OFI) for Quality?

Episode 247

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Global Medical Device Podcast

Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

Episode 246

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Global Medical Device Podcast

How To Select A Contract Manufacturer

Episode 245

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Global Medical Device Podcast

A Regulatory Gap Analysis of FDA's Systems & Policies

Episode 244

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Global Medical Device Podcast

Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat

Episode 243

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Global Medical Device Podcast

Tips For Being Prepared Post-EUA (Emergency Use Authorization)

Episode 242

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Global Medical Device Podcast

Understanding the UDI System for Medical Devices

Episode 241

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Global Medical Device Podcast

How Augmented Reality (AR) Is Revolutionizing Healthcare

Episode 239

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Global Medical Device Podcast

Why FDA Is Prioritizing Clinical Decision Support Software & Why You Should Care

Episode 238

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Global Medical Device Podcast

Why Usability Matters

Episode 237

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Global Medical Device Podcast

A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology

Episode 236

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Global Medical Device Podcast

What Are The Top Compliance Issues Plaguing Medical Device Manufacturers?

Episode 235

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Global Medical Device Podcast

Setting the Record Straight on Usability & Human Factors

Episode 234

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Global Medical Device Podcast

Project Management for Product Development of Medical Devices

Episode 233

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Global Medical Device Podcast

Assessing the Global Regulatory Landscape

Episode 232

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Global Medical Device Podcast

Quality Insights from a 40+ Year Veteran of the Medical Device Industry

Episode 231

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Global Medical Device Podcast

When to Throw the Least Burdensome Flag on FDA

Episode 230

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Global Medical Device Podcast

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Episode 229

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Global Medical Device Podcast

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Episode 228

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Global Medical Device Podcast

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Episode 227

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Global Medical Device Podcast

Meet a Guru: Maryann Mitchell

Episode 226

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Global Medical Device Podcast

Why Storytelling Matters for Medical Device Companies

Episode 225

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Global Medical Device Podcast

A Breakthrough Device that Aims to Prevent Osteoporosis

Episode 224

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Global Medical Device Podcast

Understanding FDA's New Intended Use Rule and its Implications

Episode 223

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Global Medical Device Podcast

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Episode 222

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Global Medical Device Podcast

Tips for Running Better Management Reviews

Episode 221

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Global Medical Device Podcast

Meet a Guru: Ryan Behringer

Episode 220

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Global Medical Device Podcast

Navigating the MedTech Cybersecurity Ecosystem

Episode 219

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Global Medical Device Podcast

Managing Clinical Data Activities

Episode 218

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Global Medical Device Podcast

Explaining the Role of Importer under EU MDR

Episode 217

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Global Medical Device Podcast

Preparing Your Pre-Submission with the Content FDA Wants to See

Episode 216

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Global Medical Device Podcast

How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021

Episode 215

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Global Medical Device Podcast

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development

Episode 214

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Global Medical Device Podcast

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

Episode 213

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Global Medical Device Podcast

How Mindset Training Can Help Your Team Operate at Peak Performance

Episode 212

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Global Medical Device Podcast

Examining the HHS Proposal for Premarket Notification Exemptions

Episode 211

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Global Medical Device Podcast

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

Episode 210

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Global Medical Device Podcast

Building Your Brand as a Medical Device Professional

Episode 209

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Global Medical Device Podcast

Understanding the Value of a Medical Device Guru

Episode 208

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Global Medical Device Podcast

Meet a Guru: Etienne Nichols

Episode 207

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Global Medical Device Podcast

Meet a Guru: Laura Court

Episode 206

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Global Medical Device Podcast

Regulatory Tips & Pointers from a Former FDA Reviewer

Episode 205

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Global Medical Device Podcast

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

Episode 204

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Global Medical Device Podcast

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Episode 203

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Global Medical Device Podcast

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

Episode 202

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Global Medical Device Podcast

Managing Business Risk as a Medical Device Company

Episode 201

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Global Medical Device Podcast

Waterfall vs. Agile: Battle of the Product Development Methodologies

Episode 200

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Global Medical Device Podcast

For the Love of Internal Auditing

Episode 199

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Global Medical Device Podcast

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

Episode 198

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Global Medical Device Podcast

Knowing vs. Doing as Medical Device Professionals

Episode 197

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Global Medical Device Podcast

Pivoting Operations to Meet PPE Demand during Pandemic

Episode 196

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Global Medical Device Podcast

Pros & Cons of Being a Physician turned MedTech Inventor

Episode 195

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Global Medical Device Podcast

3 Systems of Risk for Medical Devices from FDA

Episode 194

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Global Medical Device Podcast

Quality Management for IVD Devices vs Medical Devices

Episode 193

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Global Medical Device Podcast

Understanding the Investigational Device Exemption (IDE) Process

Episode 192

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Global Medical Device Podcast

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

Episode 191

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Global Medical Device Podcast

Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients

Episode 190

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Global Medical Device Podcast

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

Episode 189

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Global Medical Device Podcast

Meet a Guru: Sara Adams

Episode 188

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Global Medical Device Podcast

Why the PMA Process is so Dreaded by Manufacturers in the US Market

Episode 187

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Global Medical Device Podcast

Building a Startup in the MedTech Industry

Episode 186

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Global Medical Device Podcast

Meet a Guru: Karen Schuyler

Episode 185

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Global Medical Device Podcast

Visualizing a Medical Device through Illustrations, Animations, and other Artwork

Episode 184

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Global Medical Device Podcast

Everything you Need to Know about SaMD from an FDA Perspective

Episode 183

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Global Medical Device Podcast

Preparing for Remote and On-Site Inspections and Audits

Episode 182

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Global Medical Device Podcast

How does EU MDR impact your Quality Management System?

Episode 181

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Global Medical Device Podcast

Virtual Auditing in a Post-COVID World of Digital Compliance

Episode 180

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Global Medical Device Podcast

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

Episode 179

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Global Medical Device Podcast

Prioritizing Medical Device Reimbursement During Product Development

Episode 178

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Global Medical Device Podcast

5 Actionable Lessons Learned from the RADx Initiative by NIH

Episode 177

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Global Medical Device Podcast

What are the Strategic Priorities for CDRH in 2021?

Episode 176

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Global Medical Device Podcast

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

Episode 174

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Global Medical Device Podcast

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

Episode 173

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Global Medical Device Podcast

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

Episode 172

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Global Medical Device Podcast

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Episode 171

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Global Medical Device Podcast

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Episode 170

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Global Medical Device Podcast

What Goes into Designing Devices for Military and Emergency Applications?

Episode 169

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Global Medical Device Podcast

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

Episode 168

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Global Medical Device Podcast

Positive and Negative Impacts of EUA on the Medical Device Industry

Episode 167

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Global Medical Device Podcast

Why Biocompatibility Should be Addressed by Every Medical Device Company

Episode 166

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Global Medical Device Podcast

Meet a Guru: Erica Loring

Episode 165

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Global Medical Device Podcast

What is a Multiple Function Device?

Episode 164

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Global Medical Device Podcast

Challenges related to Home Use Devices

Episode 163

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Global Medical Device Podcast

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

Episode 162

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Global Medical Device Podcast

How Jon Speer Met His Most Frequent Guest: Mike Drues

Episode 161

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Global Medical Device Podcast

Meet a Guru: Wade Schroeder

Episode 160

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Global Medical Device Podcast

What are the Audit Etiquette Rules I Should be Following?

Episode 159

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Global Medical Device Podcast

Meet a Guru: Tom Rish

Episode 158

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Global Medical Device Podcast

Addressing Clinical Trial Challenges & Concerns during COVID-19

Episode 157

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Global Medical Device Podcast

Protecting the Intellectual Property of your Medical Device Technology

Episode 156

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Global Medical Device Podcast

Meet a Guru: Jesseca Lyons

Episode 155

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Global Medical Device Podcast

How to Build a QMS for a Medical Device

Episode 154

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Global Medical Device Podcast

Meet a Guru: Taylor Brown

Episode 153

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Global Medical Device Podcast

What is Regulatory Due Diligence for Medical Devices?

Episode 152

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Global Medical Device Podcast

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

Episode 151

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Global Medical Device Podcast

How Being Strategic During A Career Transition Can Yield The Best Opportunities

Episode 150

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Global Medical Device Podcast

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

Episode 149

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Global Medical Device Podcast

How to Construct an Effective Regulatory Strategy

Episode 148

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Global Medical Device Podcast

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

Episode 147

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Global Medical Device Podcast

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

Episode 146

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Global Medical Device Podcast

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

Episode 145

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Global Medical Device Podcast

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

Episode 144

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Global Medical Device Podcast

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

Episode 143

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Global Medical Device Podcast

How to Approach Verification and Validation for Cloud Software

Episode 142

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Global Medical Device Podcast

Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives

Episode 141

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Global Medical Device Podcast

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

Episode 140

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Global Medical Device Podcast

How to Integrate Usability into your Medical Device

Episode 139

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Global Medical Device Podcast

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

Episode 138

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Global Medical Device Podcast

How to Leverage IEC 62304 to Improve SaMD Development Processes

Episode 137

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Global Medical Device Podcast

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

Episode 136

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Global Medical Device Podcast

How to Choose the Right FDA Regulatory Pathway for your Device

Episode 135

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Global Medical Device Podcast

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

Episode 134

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Global Medical Device Podcast

4 Parts to Interviewing Candidates for Medical Device Roles

Episode 133

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Global Medical Device Podcast

5 Tips for Hiring Medical Device Advisors

Episode 132

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Global Medical Device Podcast

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

Episode 131

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Global Medical Device Podcast

Navigating the Twists and Turns of Change Management for Medical Devices

Episode 130

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Global Medical Device Podcast

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

Episode 129

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Global Medical Device Podcast

5 Myths about QA/RA Recruiting in the Medical Device Industry

Episode 128

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Global Medical Device Podcast

How to Solve the Medtech Value Equation with Quality Data

Episode 127

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Global Medical Device Podcast

Why Supplier Quality Management Is So Important

Episode 126

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Global Medical Device Podcast

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

Episode 125

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Global Medical Device Podcast

Preparing for EU MDR

Episode 124

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Global Medical Device Podcast

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

Episode 123

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Global Medical Device Podcast

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

Episode 122

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Global Medical Device Podcast

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

Episode 121

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Global Medical Device Podcast

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Episode 120

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Global Medical Device Podcast

Challenges with Pediatric Medical Devices

Episode 119

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Global Medical Device Podcast

Implementing Changes to SaMD under New EU MDR

Episode 118

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Global Medical Device Podcast

Career Tips for QA/RA Professionals in the Medical Device Industry

Episode 117

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Global Medical Device Podcast

Right-sizing your QMS

Episode 116

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Global Medical Device Podcast

Challenges with Pediatric Medical Devices

Episode 115

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Global Medical Device Podcast

When Should You Start a QMS?

Episode 114

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Global Medical Device Podcast

How General Wellness Devices Have Opened a Pandora's Box of Confusion

Episode 113

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Global Medical Device Podcast

Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

Episode 112

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Global Medical Device Podcast

Importance of Software Requirements in Product Development

Episode 111

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Global Medical Device Podcast

4 Facts That May Surprise You About FDA

Episode 110

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Global Medical Device Podcast

Design History File Ready Ideation: An Innovative Approach To Product Development

Episode 109

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Global Medical Device Podcast

Looking at the Sunset of FDA's Alternative Summary Reporting Program

Episode 108

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Global Medical Device Podcast

Challenges with MedTech Innovation

Episode 107

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Global Medical Device Podcast

Is Your Medical Device Company CAPA Happy?

Episode 106

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Global Medical Device Podcast

Integrating Human Factors into Design Controls to Improve Patient Outcomes

Episode 105

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Global Medical Device Podcast

Greenlight Guru In the Classroom: A University's Real-world Approach

Episode 104

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Global Medical Device Podcast

EU MDR: Not All Doom and Gloom

Episode 103

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Global Medical Device Podcast

Biocompatibility Nuances and its Impact on Medical Devices

Episode 102

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Global Medical Device Podcast

How to Make De Novo a Viable Option for your Medical Device

Episode 101

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Global Medical Device Podcast

The 100th Episode: A Few of My Favorite Moments

Episode 100

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Global Medical Device Podcast

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

Episode 99

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Global Medical Device Podcast

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

Episode 98

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Global Medical Device Podcast

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

Episode 97

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Global Medical Device Podcast

How and When to Consider Human Factors

Episode 95

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Global Medical Device Podcast

Who Should Own Your QMS?

Episode 94

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Global Medical Device Podcast

Design Validation vs. Human Factors Validation

Episode 93

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Global Medical Device Podcast

Medical Device Product Development Value Proposition

Episode 92

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Global Medical Device Podcast

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

Episode 91

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Global Medical Device Podcast

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?

Episode 90

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Global Medical Device Podcast

Aligning True Quality and Compliance with MDDAP

Episode 89

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Global Medical Device Podcast

Explaining the Significance of Voluntary Consensus Standards

Episode 88

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Global Medical Device Podcast

Medical Device Industry Predictions for 2019

Episode 87

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Global Medical Device Podcast

FDA Plans to Modernize 510(k) - Is the Sky Falling?

Episode 86

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Global Medical Device Podcast

Understanding the Blurred Lines Between Consumer Tech and MedTech

Episode 85

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Global Medical Device Podcast

Understanding The Differences Between Clearance vs Approval vs Granted

Episode 84

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Global Medical Device Podcast

Streamlining The Device Marketing Authorization Process

Episode 83

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Global Medical Device Podcast

The New Special 510(k)

Episode 82

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Global Medical Device Podcast

What's New With PMAs

Episode 81

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Global Medical Device Podcast

How to Efficiently Raise Funds for Your Medical Device Company

Episode 80

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Global Medical Device Podcast

7 Habits of Highly Effective True Quality Medical Device Professionals

Episode 79

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Global Medical Device Podcast

Regulatory Tips & Observations from a Former FDA Reviewer

Episode 78

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Global Medical Device Podcast

Questions to Ask Before Hiring Your Consultant

Episode 77

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Global Medical Device Podcast

What You Need to Know About The FDA CDRH Experiential Learning Program

Episode 76

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Global Medical Device Podcast

Latest Updates on CDRH Standards Program and IEC 60601

Episode 75

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Global Medical Device Podcast

15 Habits of Highly Effective Regulatory Professionals

Episode 74

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Global Medical Device Podcast

How to Embrace Risk for Safer Devices

Episode 73

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Global Medical Device Podcast

What you Need to know About FDA's Progressive Programs

Episode 72

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Global Medical Device Podcast

What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

Episode 71

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Global Medical Device Podcast

The Bleeding Edge: Lessons Learned for the Medical Device Industry

Episode 70

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Global Medical Device Podcast

AI Explainability: What that Means and Why it Matters in the Medical Device Industry

Episode 69

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Global Medical Device Podcast

How Human Factors Impact Your Medical Device

Episode 68

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Global Medical Device Podcast

How to Think About Quality and Regulatory as Your Company Scales

Episode 67

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Global Medical Device Podcast

How to Design for Compliance with IEC60601

Episode 66

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Global Medical Device Podcast

FDA Allows Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

Episode 65

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Global Medical Device Podcast

How to Use the Abbreviated FDA 510(K) Pathway to Your Advantage

Episode 64

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Global Medical Device Podcast

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not be as Scary as You Think)

Episode 63

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Global Medical Device Podcast

Tips, Tricks & Best Practices for Complying with ISO 13485:2016

Episode 62

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Global Medical Device Podcast

Helping to Prepare Biomedical Engineers Entering the Workforce

Episode 61

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Global Medical Device Podcast

How to Ensure Your Quality Management System is Effective and Benefits Patients

Episode 60

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Global Medical Device Podcast

5 Most Common Problems with Your CAPA System

Epsidoe 59

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Global Medical Device Podcast

How to Determine the Operational Quality of a Quality System Using a Performance Assessment

Episode 58

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Global Medical Device Podcast

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

Episode 57

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Global Medical Device Podcast

Evaluating FDA's "New" Proposed Fast-Track Alternative Approach to the 510(k) Pathway

Episode 56

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Global Medical Device Podcast

An Overview of What Medical Device Developers Need to Know About Human Factors

Episode 55

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Global Medical Device Podcast

Challenges with Applying Risk Management Throughout the Manufacturing Process

Episode 54

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Global Medical Device Podcast

Common Mistakes That Can Tank Your 510(k) Submission

Episode 53

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Global Medical Device Podcast

How to Use Real-Word Evidence for Medical Device Regulatory Decisions

Episode 52

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Global Medical Device Podcast

Lessons to Be Learned From Recent FDA Inspections

Episode 51

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Global Medical Device Podcast

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

Episode 50

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Global Medical Device Podcast

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

Episode 49

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Global Medical Device Podcast

Comparing FDA Submission Types: 510(k) VS. De Novo VS. 513(G) VS. Pre-Submission

Episode 48

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Global Medical Device Podcast

How Process Excellence Leads to Product Excellence

Episode 47

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Global Medical Device Podcast

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Episode 46

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Global Medical Device Podcast

Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

Episode 45

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Global Medical Device Podcast

Understanding the Connection Between Complaints, CAPAs, and MDRs

Episode 44

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Global Medical Device Podcast

The Intersection of Medical Device Usability and Risk Management

Episode 42

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Global Medical Device Podcast

How FDA Interacts with Medical Devices When They Are Imported into the US

Episode 41

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Global Medical Device Podcast

How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster

Episode 40

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Global Medical Device Podcast

An Overview of What Device Makers Need to Know About CAPA

Episode 39

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Global Medical Device Podcast

How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

Episode 38

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Global Medical Device Podcast

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

Episode 37

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Global Medical Device Podcast

What Devicemakers Need to Know About Medical Device Reporting (MDR)

Episode 36

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Global Medical Device Podcast

How Phagenesis Is Using Regulatory Affairs as They Develop a Treatment for Dysphagia

Episode 35

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Global Medical Device Podcast

2016 Medical Device Regulatory Trends Year in Review

Episode 34

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Global Medical Device Podcast

Using the Bucket Method for Medical Device Risk Management w/ Mike Drues

Episode 33

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Global Medical Device Podcast

Tips for Success When It Comes to IEC 60601 with Leo Eisner

Episode 32

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Global Medical Device Podcast

Zebra Medical Technologies: How a New Breed of Medical Device Companies Is Leveraging Technology

Episode 31

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Global Medical Device Podcast

Understanding the New FDA Guidance on Changes to 510(k)

Episode 30

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Global Medical Device Podcast

What Device Makers Need To Know About The FDA Pre-Submission Process (Part Two)

Episode 29

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Global Medical Device Podcast

Preparing for the Changes to the EU Medical Device and In-Vitro Diagnostics Regulations

Episode 28

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Global Medical Device Podcast

Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues

Episode 27

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Global Medical Device Podcast

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Episode 26

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Global Medical Device Podcast

How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

Episode 25

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Global Medical Device Podcast

Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer

Episode 24

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Global Medical Device Podcast

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

Episode 23

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Global Medical Device Podcast

Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner

Episode 22

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Global Medical Device Podcast

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

Episode 21

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Global Medical Device Podcast

Tips to Help You Prepare for an FDA Inspection

Episode 20

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Global Medical Device Podcast

What Device Makers Need to Know About Design Verification and Validation with Mike Drues

Episode 19

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Global Medical Device Podcast

Integrating Business Elements into Your Product Development Process with Therese Graff

Episode 18

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Global Medical Device Podcast

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Episode 17

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Global Medical Device Podcast

The Difference Between Intended Use and Indications of Use with Mike Drues

Episode 16

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Global Medical Device Podcast

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong

Episode 15

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Global Medical Device Podcast

Medical Device Product Development Project Management Best Practices With Peter Sebelius

Episode 14

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Global Medical Device Podcast

Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

Episode 13

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Global Medical Device Podcast

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson

Episode 12

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Global Medical Device Podcast

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

Episode 11

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Global Medical Device Podcast

Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

Episode 10

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Global Medical Device Podcast

How To Identify, Quantify & Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

Episode 9

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Global Medical Device Podcast

How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues

Episode 8

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Global Medical Device Podcast

Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

Episode 7

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Global Medical Device Podcast

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

Episode 6

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Global Medical Device Podcast

Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's

Episode 5

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Global Medical Device Podcast

Risk Management from a Regulatory & Product Development Point of View

Episode 4

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Global Medical Device Podcast

How to Improve Your Medical Device Design Reviews Bonus Episode

Episode 3 Plus

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Global Medical Device Podcast

How To Improve Your Medical Device Design Reviews

Episode 3

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Global Medical Device Podcast

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

Episode 2

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Global Medical Device Podcast

Best Practices for Implementing Design Controls for the Medical Device Industry

Episode 1

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