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Medical Device Reporting: The Do's and Don'ts

Building a Partnership with your Regulatory Consultant

Bringing a Self-Funded Medical Device to Market

Managing Risk in Clinical Investigations

Speaking the Language of IVD

Is It Possible to "Buy" a QMS?

Ultimate Guide to Clinical Data Management in MedTech

Project Management in MedTech

FDA's Voluntary Improvement Program

The State of UDI Across the World

Quality Myths & Lessons Learned Part II

Mastering the Pitch: MedTech Innovations from Concept to Market

Monarch Medical Makes Sense of Document Management With Greenlight Guru Quality

HTD Health Chooses Greenlight Guru Quality for a Modern, SaMD-Friendly eQMS

How Creo Medical Streamlined Innovation and Development with Greenlight Guru's QMS Software

How Hart Biologicals Cut Audit Prep Time in Half with a Purpose-Built QMS Platform

Avenda Health Gets SaMD Product to Market Easier with Greenlight Guru’s Purpose-Built QMS

Modernizing Your QMS to Reduce Risk, Improve Quality & Drive Innovation

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

To Commercialization & Beyond True Quality Summit Series

How a Class III Device Company Passed Their ISO 13485:2016 Re-Certification Audit with a Modern QMS and Industry Expertise

Refuse to Accept (RTA) & Additional Information Requests (AIR): How to Avoid Problems with Your Medical Device Submission

21 CFR Part 11: A Complete Guide

The Ugly Truth About Paper-Based QMS - Making the Switch to eQMS

Ultimate Guide to Postmarket Surveillance of Medical Devices

Ultimate Guide to ISO 13485 for Medical Devices QMS

How to Create Your DHF/TF & RMF for a Hardware or Software Medical Device

Beginner's Guide to Design Verification & Design Validation for Medical Devices

How to Use eConsent Efficiently in Medical Device Studies

Implementing an eQMS after switching from Paper

MDR by the Numbers: Leveraging New Data for Implementation Planning

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

Tenacore Passes ISO 13485:2016 Recertification Audit with the Help of Greenlight Guru’s Modern Platform

Medical Device Classification Guide - How To Determine Your Device Class

Monitored Therapeutics, Inc: Building an Audit-ready QMS in 3 Months

Ultimate Guide to Device Class Requirements under EU MDR

FDA Digital Health Updates: What changed in 2022 and what should you expect in 2023?

Ultimate Guide to IVDR for In Vitro Diagnostic Medical Device Companies

Regulatory Due Diligence: Why Pay for Information You Can Get for Free?

Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success

How to Prepare for IVDR

The Ultimate Guide To Design Controls For Medical Device Companies

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

Ultimate List of ISO Standards for Medical Devices

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Extending IEC 62304’s Software Lifecycle Principles to Electrical and Mechanical in Medical Device Design

Ultimate Guide to Supplier Management for Medical Device Companies

Usability Testing: Why can’t we get it right?

Connecting Computer System Validation to Daily Operations

Ultimate Guide to UDI for Medical Devices

How to Ensure Your State of Affairs for EU MDR is State of the Art

3 Common Problems with Design Controls (and the Solutions)

MDR Transition and Tech File Changes: What Medical Device Companies Need to Know

Integrating Cloud & Modern Computing Technologies into the Operation of Your Medical Device

How SOLIUS Replaced Paper with eQMS to Gain ISO 13485:2016 Certification in Weeks

What Role Should Quality Play in Bringing a Medical Device to Market?

Bridging the Gap Between Development and Regulatory Teams

How to Survive an FDA Inspection

How to Proactively Predict & Mitigate Risk throughout the Supply Chain

Special Controls: What Are They & How Can We Use Them To Our Advantage?

How to Prepare for the FDA Pre-Submission Process - Free Webinar

ISO 13485:2016 Transition Planning - Webinar

Risk Management for Medical Devices - Webinar

Medical Device Design Controls - Free Webinar Series

FDA 483 and Warning Letters: How to Avoid and Respond - Webinar

Clinical Evaluation in the EU for Medical Devices: Understanding the Changes in MEDDEV 2.7.1 Rev 4 and Their Impact

Effective Medical Device Product Development Project Management (And How To Avoid the Most Common Pitfalls) - Webinar

FDA 510(k) Submission Tips, Tricks and Timelines from a Former FDA Reviewer [Free Webinar]

How to Prepare for the New EU In Vitro Diagnostic Regulations (IVDR) [Free Webinar]

How to Simplify Compliance to the new ISO 13485:2016 Quality Management Standard - Webinar

How to Prepare for the New EU Medical Device Regulations (MDR) [Free Webinar]

8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program [Free Webinar]

15 Steps to Get Approval to IEC 60601-1 [Free Webinar]

5 Things the Medical Device Industry Should Expect in 2017 - Webinar

What You Need to Know About Life with FDA After Your Device Gains Clearance [Free Webinar]

Understanding the Many Connotations of Risk in Medical Device Development [Free Webinar]

How to Prepare for a Successful Design Transfer [Free Webinar]

How to Implement (And Maintain) a Bulletproof Medical Device QMS

Understanding the Medical Device Single Audit Program (MDSAP) & How To Prepare for It [Free Webinar]

Top 10 Most Significant Changes Introduced by the new EU MDR (And How to Avoid the Common Mistakes)

How to Create a Risk-based CAPA Process

Medical Device Change Management Best Practices [Free Webinar]

How Design Controls & Risk Management Best Practices Reduce Customer Complaints & CAPAs

Advanced Strategies and Tactics for Using the De Novo Pathway

What You Need to Know About Medical Electrical Standards Updates

Demystifying the FDA's Human Factors Guidance

How Software Can Be Leveraged to Streamline Device Development

Regulatory Intelligence (Mis)Management in the Medical Device Industry

General Wellness Devices & Wearables: Regulatory Options You Need to Know

A Timeline to Comply with ISO 13485:2016 (And What You Need to Be Doing Today)

Bridging User Needs & Design Requirements

FDA's Case for Quality: What, Why, and How? Changing the Regulatory Paradigm

10 Things You Must Know About Updating Your Technical Files to Comply with EU MDR

FDA’s Case for Quality: Voluntary Pilot Program Details and Status Update

The Pre-Market Approval (PMA): Is it really as bad as so many think?

Quality VS Compliance Metrics & What's Next for FDA's Case for Quality Pilot

FDA's Case for Quality: Simplifying the Regulatory Activities

How to Conquer Supplier Management for Medical Device Companies

Standards – Makes the Medical Device World go Around

5 QMS Elements that must Connect to your Design Control for an Effective, Audit Proof Process

The 510k and Substantial Equivalence: Why do so many get it wrong?

FDA's Case for Quality Webinar Series

EU MDR: How do I interpret the new regulations and what do I need to do to be compliant?

When Design Input Requirements Go Wrong

Prepping your QMS for EU MDR

How to Avoid Common Problems with your Design, Risk, and Validation Documentation

UX for Medical Devices: Designing for the Evolving Environment of Technology, Safety, Regulation and Recalls

Why User Needs Matter & Their Benefits in Streamlining Device Design and Development

Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive

Why Design Validation is More Than Testing: How do we validate our validation?

Quality Leaders' Playbook for Driving Executive Engagement with Quality Systems

Breakthrough Designation Program: Is this an option for my medical device?

10 Steps to Preparing Your 510(k) Submission (And How to Avoid the Common Pitfalls)

How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device

How and When to Register EU Medical Devices and Report UDI Information to EUDAMED

How and When to Start Documenting Your Design Controls with DHF Ready Ideation

Post-Market Surveillance for Medical Devices and Combination Products: If a device is FDA cleared or approved, can we assume it’s safe and effective?

An Exclusive Look at the New Changes to ISO 14971:2019 & TR 24971:2019

Implementing Best Practice Medical Device Change Control Processes (While Avoiding Common Pitfalls)

Beyond Design Controls 101: Following the Regulation vs. Understanding Its Intent

How to Use UX to Streamline Medical Device Product Cycles

Are You Sure You Know the Best Regulatory Pathway for Your New Medical Device?

How can Medical Device Companies use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?

3 Ways Medical Device Companies Working Remote are Leveraging QMS Software to Foster Innovation and Collaboration

How to Integrate Risk Management throughout the Product Lifecycle in the Coming Decade

Understanding the Medical Device Classification System: From Basics to Beyond – Using Classification to your Competitive Advantage

Verification & Testing Strategies for Compliance with ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1

Insider’s Look at the IEC 60601 Amendments: Detailed Guidance from Committee Member Responsible for Changes

How to Implement and Maintain a Modern CAPA System while Avoiding Common Pitfalls

Best Tools & Tricks for Meeting IVDR Requirements to Obtain CE Marking

When Do We Need FDA’s Permission to Market Our Device and When Do We Not?

Change Management and Risk Management: How do we connect the dots and what happens if we don’t?

How to Integrate Cybersecurity into Your Existing Medical Device Development Lifecycle

Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device

Combination Products: What Are They, Why Are They Important & Why Should Medical Device Professionals Care?

Attention ⚠️ ISO 15223-1 4th Edition is Almost Here: How to Update your Medical Device Labeling to Comply with the New Requirements

5 Key Points to Consider in Design Transfer of Medtech

Demystifying the Breakthrough Device Designation (BDD) & Safer Technologies (STeP) Processes

Human Factors Engineering: The Worldwide Guide for Medical Device Manufacturers

Tips & Tricks for Customizing a Clinical Trials Program for your Medical Device, IVD, or Digital Therapeutic that Satisfies Regulators, Investors & Patients

How to Ace Your Internal Audits in 2022

The Power of 3D-Printed Medical Devices: Proven Regulatory Strategies & Quality Recommendations to Use for Additive Manufacturing

The “New” 510k: How Do You Show Substantial Equivalence Without Using A Predicate?

Breakthrough Device Designation & Its Impact on Reimbursement

Notified Body + Manufacturer Face-off: Inside Scoop from Both Sides on How to Address MDR Misalignment

How to Effectively Implement the New ISO 14971:2019 & Maintain Your Current Risk File

Is Regulation Necessary for Quality? How to Improve Your Product & Bottom Line with Compliance & a QMS

Letter-to-File 101: Are You Sure You're Preparing Yours Correctly?

Building Your BOM: 3 Ways To Manage Your Product Information With Full Traceability

Strategies for Ensuring a Medical Device released under EUA will stay on the market after EUA expires

UDI Product Data and EUDAMED, Get Onboard!

Putting Together the Pieces for Success with Greenlight Guru

How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

Ultimate Guide to QA & RA in Medical Device 3D Printing

Case Study: How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical

Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification

FDA vs. EU Regulatory Pathways: Factors Every Startup Must Consider with Go-to-Market Strategy

Centese Trades in Paper-based QMS for Greenlight Guru Quality & Achieves 510(k) Clearance

How to Prepare for and Manage Audits/Inspections across Global Markets

5 Steps to Faster-to-Market, More Profitable Medical Devices

Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

Case Study: How Delta Development Fast-tracked R&D Down to 1 Year by Implementing a Medical Device QMS

Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means

3 Powerful Ways to Revolutionize your Approach to Closed-Loop Quality System Traceability

3 Reasons Why Closed-Loop Traceability is a QMS Must

Case Study: How Flexlogical Is Making Quality A Competitive Advantage By Adopting A Data-driven Approach With their Quality System

The Art of Defining Design Inputs And Design Outputs

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

Tips for Success with IEC 60601 for Electrical Medical Devices

EU MDR Implementation Guide

Passing MDSAP Audit & Getting FDA Approval Just Weeks After Implementing Greenlight Guru Quality

5 Dos and Don'ts when Choosing a QMS Solution for your Medical Device Company

Complete Guide to Bringing a Medical Device to Market

Ultimate Guide to Agile Design and Development for Medical Devices

10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]

The Essential Guide to Preparing your QMS for EU MDR

Why Flexible Design Reviews Matter for Medical Device Product Development

Best Practices for Effective Medical Device Design Reviews

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

15 Reasons Why Medical Device Companies Choose Greenlight Guru

Why Your Company Needs a QMS Software or eQMS

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 15X in SIX Years

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

ISO 13485:2016 - Understanding the Changes

How to Perform a Successful Internal Quality Audit [Free Webinar]

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru [Case Study]

Why Integrating Business Elements into Your Medtech Development Process Is So Important

The Risk Management + Design Controls Connection: What Device Makers Need to Know

The Definitive Guide to Responding to FDA 483 Observations and Warning Letters

The Greenlight Guru Advantage - More Than QMS Software [Customer Video Testimonial]

LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development

Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru

Bringing Augmented Reality MedTech to Market

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

Meet a Guru: Maryann Mitchell

Early Stage Territory Planning for Medical Device Companies

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

Shaking Things Up: What's Next for the Global Medical Device Podcast

Determining User Needs for Your Medical Device

Systematic Literature Review for EU MDR

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Understanding The Differences Between Clearance vs Approval vs Granted

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

Meet a Guru: Sara Adams

How to Build a QMS for a Medical Device

The Intersection of Medical Device Usability and Risk Management

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

Integrating Business Elements into Your Product Development Process with Therese Graff

Navigating the Twists and Turns of Change Management for Medical Devices

Who Should Own Your QMS?

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

What are the Top Compliance Issues Plaguing Medical Device Manufacturers?

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

Prioritizing Medical Device Reimbursement During Product Development

Project Management for Product Development of Medical Devices

5 Actionable Lessons Learned from the RADx Initiative by NIH

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

Latest Updates on CDRH Standards Program & IEC 60601

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

What's New With PMAs

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

What is Regulatory Due Diligence for Medical Devices?

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

Demystifying the De Novo Process

Fraud in the Healthcare Industry & the Role of Whistleblowers

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

Preventing the Death of Medical Device Sales

The Future of Reprocessed Used Medical Equipment

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

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

Questions to Ask Before Hiring Your QA/RA Consultant

Protecting the Intellectual Property of your Medical Device Technology

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

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

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

Aligning True Quality and Compliance with MDDAP

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

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

Common Mistakes That Can Tank Your FDA 510(k) Submission

Challenges for Regulatory Submission: EU vs. US

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

Challenges with MedTech Innovation

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

Challenges with Pediatric Medical Devices

EU MDR: Not All Doom and Gloom

Packaging Validation Best Practices

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

Examining the HHS Proposal for Premarket Notification Exemptions

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

Why Storytelling Matters for Medical Device Companies

Overcoming Submission Deficiencies due to Biocompatibility

Understanding the UDI System for Medical Devices

EUA and the Impending Transition

Meet a Guru: Tom Rish

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

Medical Device Product Development Project Management Best Practices with Peter Sebelius

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

How to Embrace Risk for Safer Devices

Preparing for EU MDR

Managing Clinical Data Activities

How to Select a Contract Manufacturer

We Achieved ISO Certification! Now What?

Part 2: The Theranos Loophole & Lab Developed Tests

Essentials of Sterilization for Med Device Professionals

Managing Business Risk as a Medical Device Company

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

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

Developing a Regulatory Strategy

The Bleeding Edge: Lessons Learned for the Medical Device Industry

Why Biocompatibility Should be Addressed by Every Medical Device Company

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

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

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

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

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

How Process Excellence Leads to Product Excellence

Explaining the Significance of Voluntary Consensus Standards

Achieving Operational Readiness through Good Project Management

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

Risk Management from a Regulatory & Product Development Point of View

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

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

How Human Factors Impact Your Medical Device

The New Special 510(k)

Early Feasibility Studies in Latin America

Bridging the Gap between Medical Devices and Clinical Data

How Jon Speer Met His Most Frequent Guest: Mike Drues

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

Lessons to Be Learned From Recent FDA Inspections

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

How Mindset Training Can Help Your Team Operate at Peak Performance

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

Making Your Informational Meetings with FDA Valuable & Worthwhile

How Communication Affects the Outcomes of Quality Activities

Importance of Software Requirements in Product Development

How Medical Device Intellectual Property Protection Varies by Sector

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

Building your Brand as a Medical Device Professional

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Navigating the Medical Device Single Audit Program (MDSAP)

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

The 100th Episode: A Few of My Favorite Moments

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

How to Design for Compliance with IEC 60601

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

Design Assurance: The Unsung Heroes of R&D

Challenges with Applying Risk Management Throughout the Manufacturing Process

Meet a Guru: Wade Schroeder

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

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

Meet a Guru: Etienne Nichols

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

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

What is MedTech Lifecycle Excellence?

Tips to Help You Prepare for an FDA Inspection

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

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

How Augmented Reality (AR) is Revolutionizing Healthcare

Complaint Handling with Medical Device Guru, Brittney McIver

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

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

The Future of Healthcare & How We Get There

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

Most Common Problems Found During FDA Inspections in 2022

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

4 Parts to Interviewing Candidates for Medical Device Roles

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

The Future of Cybersecurity

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

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

Understanding the Investigational Device Exemption (IDE) Process

Best Practices for Implementing Design Controls for the Medical Device Industry

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

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

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

Waterfall vs. Agile: Battle of the Product Development Methodologies

An Overview of What Device Makers Need to Know About CAPA

Integrating Human Factors into Design Controls to Improve Patient Outcomes

Virtual Auditing in a Post-COVID World of Digital Compliance

Meet a Guru: Taylor Brown

Medical Device Product Development Value Proposition

What Goes into Designing Devices for Military and Emergency Applications?

What are the Strategic Priorities for CDRH in 2021?

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

Navigating the MedTech Cybersecurity Ecosystem

Why Design Verification Matters in Medical Device Design and Development

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

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

How to Integrate Usability into your Medical Device

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

Positive and Negative Impacts of EUA on the Medical Device Industry

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

What are the Audit Etiquette Rules I Should be Following?

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

What is FDA's ASCA Pilot Program and How Does it Impact Medical Device Manufacturers?

Peeling back the Layers of HHS Proposal for 510(k) Exemptions

Preparing for Remote and On-Site Inspections and Audits

How to Solve the Medtech Value Equation with Quality Data

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

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

Building Your Regulatory Strategy for Commercialization

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

Is Your Medical Device Company CAPA Happy?

What is a Multiple Function Device?

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

How does EU MDR impact your Quality Management System?

For the Love of Internal Auditing

Quality Management for IVD Devices vs Medical Devices

How and When to Consider Human Factors

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

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

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

Addressing Clinical Trial Challenges & Concerns during COVID-19

Why Usability Matters

Guerilla Tactics for Quality Leadership

CDRH Proposed Guidance for FY 2023

eQMS in Academia: Practical Learning for Biomedical Engineering Students

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

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

Medical Device Industry Predictions for 2019

Pivoting Operations to Meet PPE Demand during Pandemic

How to Choose the Right FDA Regulatory Pathway for your Device

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

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

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

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

How To Improve Your Medical Device Design Reviews

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

A Breakthrough Device that Aims to Prevent Osteoporosis

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

Does Your CAPA Process Need a CAPA?

Building a Startup in the MedTech Industry

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

Meet a GURU: Jesseca Lyons

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Knowing vs. Doing as Medical Device Professionals

Understanding the Value of a Medical Device Guru

A Regulatory Gap Analysis of FDA's Systems & Policies

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

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

Bringing Medical Devices into the Home

Part 1: The Theranos Loophole & Lab Developed Tests

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

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

Understanding FDA’s Proposed Conformity Assessment Pilot Program

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

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

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

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

The Future of Lateral Flow Test Technology

Customer Discovery for Medical Device Companies

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

Meet a Guru: Brittani Smith

Assessing the Global Regulatory Landscape

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

Design Validation vs. Human Factors Validation

Meet a Guru: Laura Court

Building a Culture of Quality

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

Avoiding Potential Issues with your 510(k) Submission

4 Facts That May Surprise You About FDA

How to Improve Your Medical Device Design Reviews Bonus Episode

How to Efficiently Raise Funds for Your Medical Device Company

Regulatory Tips & Pointers from a Former FDA Reviewer

15 Habits of Highly Effective Regulatory Professionals

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

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

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

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

5 Tips for Hiring Medical Device Advisors

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

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

UDI and the Current State of Global Implementation

Quality Myths and Lessons Learned

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

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

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

How to Think About Quality and Regulatory as Your Company Scales

3 Systems of Risk for Medical Devices from FDA

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

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

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

Understanding the Connection Between Complaints, CAPAs, and MDRs

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

Why Supplier Quality Management Is So Important For Medical Device Companies

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

Setting the Record Straight on Usability & Human Factors

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

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

Nonbinding Feedback is a New Guidance You Should Know About

How AI Can Help You Manage Risk

Understanding the Blurred Lines Between Consumer Tech and MedTech

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

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

Tips for Running Better Management Reviews

Building Your Design Controls (and Pitfalls to Avoid)

Understanding and Handling Different Types of Feedback

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

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

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

Helping Prepare Biomedical Engineers Entering the Workforce

How to Construct an Effective Regulatory Strategy

Streamlining The Device Marketing Authorization Process

What you Need to Know about FDA's Progressive Programs

Explaining the Role of Importer under EU MDR

Understanding FDA's New Intended Use Rule and its Implications

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

Right-sizing your QMS

Biocompatibility Nuances and its Impact on Medical Devices

Regulatory Tips & Observations from a Former FDA Reviewer

Auditing the Auditor

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

The Tools that Make Clinical Investigations

Pros & Cons of Being a Physician turned MedTech Inventor

Best Practices for Clinical Evidence Management

When Should You Start a QMS?

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

Why Building Supplier Relationships Is So Important

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

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

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Corrective Action Preventive Action (CAPA) vs. Preventive Action Corrective Action (PACA):Which is the smarter approach?

In this webinar, participants will learn best practices to avoid timely and costly mistakes and creative ways to use CAPA’s (and PACA’s) to their advantage!

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November 14, 2024

Predetermined Change Control Plans (PCCP): Approving medical device changes before you make them!

With FDA’s recent expansion of PCCP eligibility, MedTech companies now have another option to approve device changes before they happen. Join regulatory expert Michael Drues, Ph.D., in this interactive session to learn best practices to avoid costly mistakes and discover creative ways to leverage PCCPs to your advantage!

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