Helping you imagine, introduce, and advance better medical technologies.
Everything You Need to Know about Electronic Data Capture (EDC) Systems
Free webinar covering the results of research on recent MDCG guidance, industry and Notified Body surveys, and personal interviews with regulatory stakeholders on first hand ...
"It’s scalable, it’s repeatable, and it’s audit-ready."
In this free webinar medical device experts from Avania and SMART-TRIAL by Greenlight Guru share advice and insights on how medical device manufacturers can optimize clinical ...
In this free webinar, SMART-TRIAL‘s PMCF expert, Jón Bergsteinsson, teams up with CEO of Evnia, Efstathios Vassiliadis, to present you with a simple, yet powerful tool, to collect ...
Greenlight Guru's annual 2023 State of Medical Device Industry Report is coming to help you understand the strategies, tactics, and technologies used today to accelerate ...
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Episode 295
“Purchasing Greenlight Guru was the best decision for our needs. Their easy-to-use eQMS, SOP Templates, and expert Guru guidance were key to us being able to successfully navigate ...
Episode 294
Access this free guide on how to plan a clinical data management setup for EDC Systems.
Access the free eBook of our Ultimate Guide to Device Class Requirements under EU MDR which provides detailed instructions on how to classify and categorize your device according ...
Register for this free webinar presented by clinical data expert and co-founder of SMART-TRIAL by Greenlight Guru, Páll Jóhannesson, and senior director of clinical operations at ...
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This free, in-depth webinar, presented by regulatory experts Kevin Go and Allison Komiyama, will discuss recent regulatory developments in the Digital Health space, how to apply ...
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A free guide supplying medical device manufacturers with 7 best practices for how to design an electronic case report form.
In-depth guide on the process of sample size calculation for medical device studies.
In-depth guide on medical device classification and requirements under EU MDR.
In this free, interactive webinar industry expert Michael Drues, PhD, explains what regulatory due diligence is for medical device professionals and how to do it, as well as how ...
Join us for a live webinar as industry experts Shawnnah Monterrey, CEO of BeanStock Ventures, Kate Burns, Senior Software Product Manager at Arthrex, and Chris DuPont, CEO of ...
Free, educational webinar covering pertinent details and established best practices on how to prepare your QMS, technical, and clinical documentation for the upcoming IVDR ...
If you don’t have a world-class Quality Management System, you may be falling behind. Your QMS can go beyond compliance as you work to enable a culture of True ...
In this free, in-depth webinar, Satyajit ‘Sat' Ketkar will explain how these principles can and should be applied to all functions of a medical device, specifically electrical and ...
Good supplier management is critical to marketing a medical device. This comprehensive guide covers everything you need to know about suppliers and purchasing controls.
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This free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, will use actual devices as case studies to take a critical look at the way we do ...
Join Proxima Clinical Research’s subject matter expert, Director of Regulatory Affairs, Isabella Schmitt, MBA, RAC, who will expand on clinical considerations for software and ...
Register for this free, in-depth webinar where Carlos Almeida, District Manager & Vice President, Engineering at SPK and Associates, will walk you through how to manage electronic ...
A comprehensive guide to UDI (Unique Device Identification) for medical device manufacturers.
MedTech’s global regulatory landscape has changed drastically over the last decade. Policies are evolving across the globe and more programs and processes are being ...
Register for this free, in-depth webinar as we discuss how State of the Art, in context of the formal MDR and MEDDEV references, impacts Technical Documentation, Risk Analysis, ...
Register for this free webinar presented by Abbas Dhilawala, CTO of Galen Data, who will describe these challenges and provide considerations that are critical for success.
By Nick Tippmann Medical Product Outsourcing July 13th, 2022
By Nick Tippmann Medical Product Outsourcing July 12th, 2022
By Nick Tippmann Medical Product Outsourcing July 8th, 2022
Register for this free, in-depth webinar presented by Rook Quality Systems Sr. Quality Manager Chandler Thames who will expand on the new MDR requirements, and provide key ...
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By Etienne Nichols Project Medtech Podcast June 27th, 2022
By Nick Tippmann Med-Tech Innovation May 17th, 2022
By Nick Tippmann 24x7 Magazine May 17th, 2022
A free, in-depth webinar covering integrating cloud and other modern computing technologies into the operation of medical devices and what cloud computing can teach us about the ...
A comprehensive guide to software as a medical device (SaMD) packed with insights into how these products are regulated and what manufacturers should expect when building one.
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A free, in-depth webinar covering the intersection and friction between development and regulatory teams, with a focus on remedies in the form of processes, tools and approaches, ...
A free, in-depth webinar covering some preventative actions that a medical device company can take to minimize the possibility of receiving a 483 which in some cases could result ...
This free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, will cover the basics of special controls, how to know if your device needs them and ...
A free, in-depth webinar covering proactive strategies for predictive risk mitigation throughout the supply chain based on core principles of Risk Based Methodologies as it ...
Episode 254
Ultimate guide supplying medical device manufacturers with an overview of both generic and specific PMCF activities, and guidance on when and how to include them in your PMCF plan.
Episode 253
A four-part comprehensive guide to help manufacturers understand the essentials of clinical evaluation for medical devices in the European Union (EU).
Episode 252
A free, in-depth webinar presented by Shawnnah Monterrey of Beanstock Ventures who will provide a detailed overview of SaMD, the latest updates to the regulations, and how to ...
A free, in-depth webinar presented by clinical data experts Páll Jóhannesson and Jón Bergsteinsson from SMART-TRIAL who will help you avoid common pitfalls that make your ...
By Etienne Nichols MedTech Intelligence March 24th, 2022
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A free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, covering the basics of how to prepare a letter-to-file the right way in order to avoid a ...
A free, in-depth webinar exploring how regulations and standards contribute to the improved safety and overall quality of medical products and directly affect cost and profit.
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A free, in-depth webinar exploring a more efficient process to control and collaborate on product development to streamline work for faster submissions and continuous ...
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True Quality 2022, Greenlight Guru's inaugural conference, is coming to San Diego June 6-8th. Learn, connect, and find inspiration at the must-attend experience for ...
Greenlight Guru's annual State of Medical Device Product Development and Quality Management Report is coming to help you understand the strategies, tactics, and technologies ...
A free, in-depth webinar covering best practices for UDI preparations and the future potential impacts to medical device manufacturers as EUDAMED requirements are becoming ...
By Jon Speer Medical Product Outsourcing January 7th, 2022
A free, in-depth webinar explaining how to conduct internal audits of core QMS functions and cross-functional collaboration methods you can use to benefit your product, QA/RA, ...
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The Raising Capital True Quality Summit Series is designed to help early-stage medical device, MedTech, and digital health company ...
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Free, in-depth webinar covering various key changes to ISO14971 and practical approaches for implementation of the new standard for both new products and legacy products.
By Nick Tippmann Medical Product Outsourcing December 3rd, 2021
"Greenlight Guru was instrumental in implementing our quality system. With them, we can bring safer, higher-quality medical devices to success while maintaining a quality ...
A free, in-depth webinar covering the inside scoop from off-the-record interviews held with both manufacturers and notified bodies to identify areas of misalignment and ...
A free, in-depth webinar covering the benefits and risks associated with FDA Breakthrough Designation and what it means for reimbursement, FDA interactions and time to ...
By Nick Tippmann MedTech Intelligence November 22nd, 2021
By Wade Schroeder Quality Digest September 2nd, 2021
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A comprehensive list of most frequently asked questions and their answers about ISO 15223-1:2021 Fourth Edition, the latest version of the international standard for the ...
Episode 233
A free, in-depth webinar covering the “new” safety and performance based 510k (sp510k).
A white paper to guide users in the medical device industry through every stage of the product development process, from evaluating manufacturing methods and 3D printing ...
Episode 232
A valuable resource to help medical device manufacturers bridge the connection between design control and risk management processes in order to design, develop, manufacture, ...
Episode 231
“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical device industry pros and understand what companies like ours go ...
“Having partners with common values is just as important as the product or services themselves.”
A free, in-depth webinar covering various additive manufacturing methods and 3D printing technologies companies can use for making medical devices, validating workflows, and ...
Episode 230
A free, in-depth webinar covering what to expect and do for a successful clinical trials program and market launch for Non-significant Risk (NSR) devices, IVDs, Software as a ...
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Episode 228
Whether you’re bringing your first device to market, or you have launched multiple already, our upcoming True Quality Summit Series is for you. There’s a variety of ...
The Risk Management True Quality Summit Series will help quality, regulatory and product development professionals and executives ...
Episode 227
Free, in-depth webinar covering the human factors engineering process and how to comply with the applicable regulatory requirements of the US, UK, EU, and other international ...
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A free, in-depth webinar covering BDD and STeP application processes and why getting these designations early in the regulatory process can help clear a device’s pathway to ...
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Episode 223
Free, in-depth webinar presented by Doug Browne, Director of Mechanical Engineering and Design Transfer at Sunrise Labs, and Ted Trask, Director of Corporate QA/RA at ...
Episode 222
A free, in-depth webinar covering the best practices for setting up an agile QMS which can be adapted and optimized concurrently with software as a medical device (SaMD) ...
Episode 221
Free, in-depth webinar presented by regulatory experts from the Greenlight Guru Regulatory Advisory Board, where they will compare and contrast FDA versus EU regulatory ...
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By Jon Speer Medical Product Outsourcing July 6th, 2021
Episode 218
By Brandon Henning Medical Product Outsourcing July 1st, 2021
Episode 217
This free, in-depth webinar will cover the latest updates of ISO 15223-1 4th Edition to help participants understand the full scope of changes and uncover actionable ...
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By Jon Speer Quality Digest, June 2nd, 2021
Episode 211
Free interactive webinar exploring ...
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"Greenlight Guru provides an Electronic Quality Management System (eQMS) for medical device companies to ensure quality standards are met without requiring that the end ...
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In this free, exclusive webinar event, Greenlight Guru founder Jon Speer will moderate a panel of industry experts in a lively discussion about audits and inspections.
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By Nick Tippmann Medical Product Outsourcing, April 29th, 2021
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A free, in-depth webinar on how manufacturers can evaluate whether biocompatibility testing and risk mitigations are necessary when making changes to a medical ...
Episode 197
By Jon Speer MedTech Intelligence, April 14th, 2021
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A free, in-depth webinar explaining how to integrate cybersecurity into existing medical device development processes, resulting in secure products and needed artifacts for ...
Episode 192
In this report, we wanted to provide you with a holistic ...
Understand what today’s medical device professionals are doing or using to accelerate product development, ensure compliance, and promote quality based on original research ...
Episode 191
By Jon Speer Medical Product Outsourcing, March 25th, 2021
Episode 190
By Jon Speer Medical Product Outsourcing, March 15th, 2021
By Jon Speer Medical Device and Diagnostic Industry, March 15th, 2021
By Jon Speer MedTech Intelligence, December 15th, 2020
Episode 189
Episode 188
"If I were to quantify it, it's days of time saved. The cost of Greenlight Guru is repaid in efficiency."
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Whether you've fully transitioned, are just getting started, or are planning to enter the EU market in the future, you won't want to miss this free virtual summit that covers ...
The two day, digital event dives into perspectives, predictions, and experiences of industry leaders and takes a deep dive into the ...
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"Greenlight Guru was the only way we could get our small team to move really quickly with a QMS."
Episode 179
A free, in-depth webinar explaining how to transform the change management process from reactive to predictive quality through AI/ML technologies that enable proactive ...
Comprehensive guide to help medical device companies learn about training management, including compliance requirements and proven ways to promote total competence of the ...
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Free interactive webinar demonstrating how to integrate change management and risk management and will share best practices using case studies from a variety of clinical ...
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By Nick Tippmann Medical Product Outsourcing, December 4th, 2020
By David DeRam Inside INdiana Business, December 3rd, 2020
By Jon Speer Medical Device and Diagnostic Industry (MD+DI), November 12th, 2020
Episode 170
Episode 169
In-depth guide covering the requirements of 21 CFR Part 820, FDA's quality system regulation for medical devices, including tips on how to comply and avoid common ...
In-depth guide for medical device companies on how to control documents and improve procedures, with actionable solutions to common problems with document control activities ...
Episode 168
By Jon Speer Quality Digest, September 29th, 2020
Episode 167
A free, in-depth webinar exploring what is and is not a regulated medical device and how manufacturers can interpret and leverage FDA's definition of a device.
A free, in-depth webinar covering the challenges medical device companies face today when demonstrating closed-loop traceability, the growing emphasis from industry ...
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By Jon Speer Medical Product Outsourcing, September 24th, 2020
By Jon Speer Quality Digest, September 8th, 2020
A free, in-depth webinar covering the best tools and tricks for manufacturers of in vitro diagnostic devices to meet IVDR requirements and obtain CE Marking.
Episode 163
By Wade Schroeder Inside INdiana Business, August 6th, 2020
Episode 162
A free, in-depth webinar covering proven methods to improve your CAPA processes and tactical approaches you can start taking today to ensure the medical devices you design, ...
Episode 161
By Jon Speer Medical Product Outsourcing, August 24th, 2020
Episode 160
A free, in-depth webinar covering the significant changes of the IEC 60601 Amendments and how medical device manufacturers and consultants can ...
Episode 159
Episode 158
By Jon Speer Medical Device and Diagnostics Industry, August 4th, 2020
By David DeRam Forbes, July 30th, 2020
Episode 157
By Jon Speer Medical Product Outsourcing, July 27th, 2020
A free in-depth webinar covering the most effective verification and testing strategies companies can implement for compliance with ISO 13485:2016, IEC 62034 / 60601-1 / 82304-1.
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Episode 153
The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device quality, regulatory, and product development professionals who drive innovation ...
A free, in-depth webinar covering the medical device classification system and how companies can use it to their competitive advantage by using best practices for ...
A free webinar reviewing the application of a modern approach to risk management (risk analysis, risk evaluation, risk control, overall residual risk evaluation, ...
By Jon Speer MedTech Intelligence, June 24th, 2020
Episode 152
Episode 151
"Showing traceability and documenting takes seconds in Greenlight Guru, compared to hours in a paper-based system."
Episode 150
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By Jon Speer Medical Product Outsourcing, May 28th, 2020
Episode 148
By Jon Speer MedTech Intelligence, May 19th, 2020
Episode 147
By Jon Speer Quality Digest, May 14th, 2020
Episode 146
By David DeRam Forbes, May 8th, 2020
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By Jon Speer MedTech Intelligence, April 27th, 2020
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This free in-depth webinar will cover how companies using turn-key, best-in-class QMS software are able to remain agile in order to innovate and outperform the ...
By Nick Tippmann Medical Product Outsourcing, April 6th, 2020
Episode 140
This free in-depth webinar will explore the Emergency Use Authorization — specifically in the context of COVID-19 — and how medical device companies can use it.
Episode 139
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Episode 137
Learn the most up to date recommendations and best practices from the ISO 14971:2019 standard and how you can start to use risk management as a tool - not a checkbox ...
This free in-depth webinar will explore all regulatory pathways to market — including the lesser-known and lesser-used ones — to help you decide which to use when for your ...
Episode 136
By Jon Speer MedTech Intelligence, March 6th, 2020
By Jon Speer Quality Digest, February 17th, 2020
The best QMS software comparison guide for medical device companies that will help you choose a quality management system solution that strategically benefits your product and ...
A free in-depth webinar outlining a process that not only fits within the regulatory parameters, but also is so effective that it shortens the typical product development cycle ...
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By Jon Speer Medical Product Outsourcing, February 13th, 2020
Episode 133
A free in-depth webinar covering the most important items that companies must understand and put into practice when developing and commercializing SaMDs.
Episode 132
By David DeRam Forbes, February 4th, 2020
By David DeRam Forbes, February 3rd, 2020
Episode 131
By Jon Speer Healthcare Business Today, January 20th, 2020
By Jon Speer Medical Product Outsourcing, January 20th, 2020
By Jon Speer Medical Design & Outsourcing, January 16th, 2020
By Jon Speer Medical Product Outsourcing, January 15th, 2020
A free in-depth webinar on industry benchmark survey findings of over 500 medical device professionals around the globe, covering the most compelling stats, biggest surprises, ...
Know what questions to ask software vendors that give your medical device company the necessary information to consider when selecting a QMS software solution.
By Jon Speer MedTech Intelligence, December 27th, 2019
A free webinar covering the design control “framework” and recommendations to effectively meet their requirements. Emphasis will be placed not only on regulatory aspects but on ...
Episode 130
Episode 129
A free webinar on how you can establish an effective medical device change control process to ensure internal consistency throughout your quality management systems and ...
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Episode 125
By Jon Speer Medical Plastics News, November 11th, 2019
A definitive guide on change management best practices to help medical device companies understand and manage changes to documents, products, processes and more.
By Jon Speer Medtech Intelligence, November 8th, 2019
Episode 124
By Jon Speer In Compliance, October 31st, 2019
A free, in-depth webinar covering the new changes to ISO 14971:2019, the international standard for medical device risk management, and its companion guidance document ISO TR ...
Episode 123
A guide to the top 5 recommended best practices that medical device companies should consider when choosing a quality management system (QMS) solution.
A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global ...
By Jon Speer Medical Design & Outsourcing, October 30th, 2019
By Jon Speer Quality Digest, October 22nd, 2019
"We wanted a QMS solution that was robust enough to grow with us, but simple enough to get us started."
In this free webinar participants will learn post-market surveillance best practices for medical devices and combination products to avoid timely and costly mistakes, as ...
Episode 122
Evan Luxon Co-founder & CEO, Centese
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Episode 120
In this free webinar participants will learn how and when to start formal design controls to improve product development through an innovative and proven approach known as DHF ...
Episode 119
In this free webinar participants will learn how and when to register EU medical devices and report Unique Device Identification (UDI) information to EUDAMED, manage UDI ...
Episode 118
Episode 117
“Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA submission.”
By Jon Speer The MedTech Conference , August 26th, 2019 How prepared is your quality management system for the new requirements of EU MDR for medical devices that ...
Episode 116
In this free webinar participants will learn how to apply Risk Management (Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation, Production and Post ...
Episode 115
Chad McClennan President, CEO, Koios Medical, Graham Anderson CFO, Koios Medical, Patricia ...
Episode 114
In-depth overview of Agile design and development processes to improve risk and quality management of medical devices that fulfill user and business needs.
Episode 113
Becky Fitzgerald Principal/Co-founder, Two Harbors Consulting
In this free webinar participants will learn about the key steps to take when preparing a 510(k) Premarket Notification and how to avoid common pitfalls that can occur during ...
Episode 112
Episode 111
Ryan Shelton Founder / CEO, PhotoniCare
By Evan Luxon, Centese (Greenlight Guru customer), Medical Product Outsourcing, June 24th, 2019. As an early-stage medical device company, it may seem simpler to ...
By David Deram, Forbes, June 13th, 2019. Quality is manifested by the level of commitment that’s invested. Quality outcomes don’t happen by chance; they are ...
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Devon Campbell Founder, Prodct LLC
Episode 107
By Jon Speer Quality Digest, June 13th, 2019
Episode 106
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In this free webinar participants will learn best practices for design validation, including how to avoid timely and costly validation mistakes and creative ways to use ...
This is the essential guide to help you prepare your Quality Management System (QMS) for the new EU MDR before the transition period ends on May 26, 2020.
Alex Ovadia CEO, Check-Cap
Schelte Post Project Manager, MR Coils
Episode 103
Episode 102
By Evan Luxon, Centese (Greenlight Guru customer) MedTech Intelligence, May 14th, 2019
By Jon Speer ECN, March 25th, 2019
Episode 101
A free webinar on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) that goes into effect May 2020, ...
Daniel Powell CEO, Spark Biomedical
Episode 100
Episode 99
By Jon Speer Quality Digest, March 19th, 2019
By Jon Speer ECN Magazine, February 14th, 2019
A free webinar about connecting empathy and purpose to gain meaningful user insights that translate into optimal design inputs and product quality in medical device ...
Episode 98
A free webinar on the ways in which UX design can mitigate human error while reducing both recalls and product development costs.
"I have a high degree of confidence that as changes to the regulations occur, I won't have to worry about being out of compliance because we are using Greenlight ...
Episode 97
"With Greenlight Guru, you've got software, but also what amounts to a personal consultant. Those connections are powerful."
"I highly recommend Greenlight Guru. They have taken a complex industry and made it into a product that’s simple to use.”
Episode 96
A free webinar on the simple ways you and your team can learn to integrate documentation best practices so you can mitigate risk and systemic issues.
David Narrow CEO, Sonavex
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Episode 93
A free webinar on the critical steps that are needed in order to prepare your Quality Management System (QMS) for the upcoming EU Medical Device Regulations (EU MDR) in ...
Episode 92
A free webinar on what happens when Design Inputs, which are widely regarded as the most important design control element, go wrong.
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Episode 88
Free webinar on how to interpret European Union’s Medical Device Regulation (EU MDR), what it means to each organization, and what you can do to be compliant in the EU.
By David Deram The Sales Evangelist, December 7th, 2018
By Jon Speer MedTech Intelligence, December 3rd, 2018
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Episode 84
By Jon Speer Medical Product Outsourcing, October 17th, 2018
Episode 83
Free webinar series presented by FDA Case for Quality Manager Cisco Vincenty in partnership with Greenlight Guru. This four-part webinar series covers the future of FDA's ...
ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices offers industry professionals everything related to the topic. Greenlight Guru eQMS ...
Episode 82
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Episode 80
Free webinar presented by the FDA and Greenlight Guru. Learn about IMDRF, its forthcoming guidance, and how its priorities play in relation to international medical electrical ...
Episode 79
This eBook provides 15 reasons you need a solution such as Greenlight Guru that provides built-in compliance, provides traceability, takes little time to implement, and is ...
By David DeRam MedTech Intelligence, October 8th, 2018
By Jon Speer Medical Design & Outsourcing, September 24th, 2018
By David DeRam DZone, August 21st, 2018
By Jon Speer Medical Product Outsourcing, August 20th, 2018
By David DeRam InformationWeek August 13th, 2018
By Jon Speer MedCity News August 8th, 2018
Episode 78
Episode 77
Free webinar presented by Kyle Rose of Rook Quality Systems and Greenlight Guru. Learn to conquer supplier management by updating your processes and using best practices to ...
Episode 76
Episode 75
We'll take you through each section of 21 CFR Part 11, FDA's regulation for electronic documentation and electronic signatures. We'll explain what the ...
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Episode 71
Learn how to manage all the changes to your medical device QMS to comply with the new regulations & standards; EU MDR, EU IVDR & ISO 13485:2016.
Paper-based quality management systems are no longer an option. The right quality management software platform can save time, money, and allow you to focus on quality.
Looking to submit your FDA 510k? This step by step guide provides step-by-step instructions on preparing an FDA 510(k) submission to gain market clearance.
The art of defining design inputs & design outputs for FDA compliance by medical device manufacturers.
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Episode 63
By Jon Speer Quality Digest June 20th, 2018
Greenlight Guru has partnered with FDA to give you the inside track on what you need to know about the Case for Quality, the changing regulatory paradigm, and what all this ...
“Not having your Design control or Risk Management can be a $20M hair cut on the valuation of your company. I’ve seen first hand a small company being courted by a bigger ...
By Jon Speer Quality Digest April 30th, 2018
By Jon Speer MedCity News April, 23rd 2018
By Jon Speer Med Device Online April 2nd, 2018
By Jon Speer MedCity News March 29th, 2018
By David DeRam Business 2 Community March 15th, 2018
By Jon Speer Medical Design & Outsourcing February 9th, 2018
By Jon Speer Medical Device and Diagnostics Industry February 8th, 2018
By Jon Speer Medical Device and Diagnostics Industry January 31st, 2018
By Greenlight Guru Med Device Online January 30th, 2018
By Jon Speer Quality Digest January 30th, 2018
By Jon Speer Med-Tech Inovation January 30th, 2018
By Jon Speer Medical Design & Outsourcing January 23rd, 2018
By David Odmark Techpoint January 16th, 2018
By Jon Speer MedCity News January 16th, 2018
By Jon Speer MedCity News December 21st, 2017
By Jon Speer Quality Digest December 19th, 2017
By Jon Speer Quality Digest November 27th, 2017
By Jon Speer Diagnostic and Interventional Cardiology November 24th, 2017
By Jon Speer Med Device Online November 17th, 2017
By Jon Speer Medical Device and Diagnostics Industry November 16th, 2017
By Jon Speer Quality Digest October 17th, 2017
By Jon Speer MedCity News October 17th, 2017
By Jon Speer Mass Device October 5th, 2017
By Jon Speer Medical Design & Outsourcing October 5th, 2017
By Jon Speer Med Device Online October 2nd, 2017
By David DeRam Entrepreneur September 27th, 2017
By Jon Speer The MedTech Conference September 21st, 2017
By Jon Speer Medical Product Outsourcing September 7th, 2017
By Jon Speer Quality Digest August 19th, 2017
By David DeRam Powderkeg August 24th, 2017
By Jon Speer Med Device Online August 22nd, 2017
By Jon Speer MedCity News August 21st, 2017
By John Speer MassDevice August 18th, 2017
By Jon Speer Medical Design & Outsourcing August 18th, 2017
By David DeRam Inside INdiana Business August 16th, 2017
By Jon Speer MedCity News June 15th, 2017
By Jon Speer MedCity News May 25th, 2017
By Jon Speer MedCity News May 15th, 2017
"As a design firm, our ISO 13485 certification is a competitive advantage. Greenlight Guru made getting it easy."
"I was actually a little nervous going into the audit, because it seemed too effortless."
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By John Speer Medical Device and Diagnostic Industry April 25th, 2017
By Jon Speer MedCity News April 13th, 2017
By Jon Speer Quality Digest March 28th, 2017
By Jon Speer MedCity News March 3rd, 2017
By Jon Speer Quality Digest February 13th, 2017
Episode 53
Episode 52
How to start using FDA design controls to your benefit today & implement a process to actual improve your medical device product development efforts.
Learn how to implement and maintain a risk-based CAPA process while avoiding the most common pitfalls at your medical device company.
Learn how modern, purpose-built software not only ensures you compliance with all the latest regulations but also frees up your engineers’ time, reduces risk, speeds time to ...
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By Jon Speer MedCity News October 16th, 2016
By Jesseca Lyons Med Device Online September 19th, 2016
By Jesseca Lyons Medical Product Outsourcing Jesseca Lyons on September 15th, 2016
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Episode 34
Episode 33
Episode 32
"Greenlight Guru has already paid for itself in the added value brought to us by successfully flying through our quality audit."
Episode 31
Episode 30
Episode 29
Episode 28
Episode 27
Episode 26
Episode 25
Episode 24
Episode 23
The results? "A tenfold increase in efficiency with Greenlight Guru."
Episode 22
Episode 21
Episode 20
Episode 19
Episode 18
Episode 17
Episode 16
Episode 15
Episode 14
Episode 13
Everything device makers need to know about the Risk Management + Design Controls connection in medical device product development.
Episode 12
If you find yourself in this situation, learn how to respond to FDA 483's & warning lettering (includes a free response template)
A step by step guide to complying with ISO 13485 and FDA quality management system requirements for medical device companies.
"I believe the quality system I've institued actually gives me a competitive advantage against a lot of the large companies I used to work for."
Episode 11
Episode 10
"Less than 15 minutes later, the auditor had observed enough evidence to grant the scope expansion."
"The proof is in the pudding. We passed our California audit with flying colors. She was in and out in 2 hours and sent us our certificate in the mail, no questions ...
Episode 9
Episode 8
Here are 15 items medical device startups need to address early on as a best practice to ensuring FDA / ISO regulatory compliance.
Episode 7
Greenlight Guru presents a step-by-step guide for determining how your medical device will be classified by U.S. FDA, European Commission, and Health Canada.
Episode 6
Episode 5
Episode 4
Episode 3 Plus
Episode 3
Episode 2
Learn exactly what design verification and design validation are, how they are the same, how they are different, and best practices for medical devices.
Episode 1
Join 200,000+ other medical device professionals outperforming their peers.