![Most Popular Medical Device Content 2024]()
2024 was an eventful year in the MedTech landscape, with plenty of changes happening within the industry. Just to name a few:
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FDA published its Final Rule on the new Quality Management System Regulation (QMSR), initiating a long awaited process of harmonization with ISO 13485:2016.
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The agency also issued its Final Rule on the phaseout of enforcement discretion for lab developed tests (LDTs), setting off a minor panic in the LDT sector.
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The EU parliament passed Regulation (EU) 2024/1860, extending the transitional period for certain in-vitro diagnostics to comply with IVDR.
Something that hasn’t changed, however, is our commitment to bringing you timely, informative, and high-quality content on all the latest updates in MedTech. Whether you prefer to read, watch, or listen, we’ve got you covered. We looked through our entire content output for the year, found our most popular blogs, webinars, and podcasts, and brought them together here—along with a bundle of our most popular tools, templates, and checklists that you can download for free.
There’s something here for everyone, so see what grabs your interest and enjoy!
BONUS RESOURCES: Click here to download a free content bundle with our top eBooks, tools, and on-demand webinars from 2024.
Top 10 Medical Device Blog Posts
The Greenlight Guru Medical Device Blog provides actionable tips, best practices and insights for better medical device quality, compliance and product development. Join 200,000+ other MedTech professionals outperforming their peers by subscribing to our newsletter.
FDA Publishes Final Rule on QMSR
![FDA Publishes Final Rule on QMSR]()
This blog post explains the FDA's new Quality Management System Regulation (QMSR), which aligns U.S. medical device standards with ISO 13485:2016 to simplify compliance and reduce redundancy.
Read the full blog post →
QMSR & the End of DMR, DHR, DHF: How FDA’s New Rule Impacts Record-Keeping
![QMSR & the End of DMR, DHR, DHF How FDA’s New Rule Impacts Record-Keeping]()
We discuss the FDA's shift from traditional record-keeping terms like DMR, DHR, and DHF to an ISO 13485:2016-aligned approach under the new QMSR.
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Step-by-Step Guide to FDA PMA Submissions for Class III Medical Devices
![Step-by-Step Guide to FDA PMA Submissions for Class III Medical Devices]()
This guide provides a comprehensive walkthrough of the FDA's Premarket Approval (PMA) process for Class III medical devices. You'll learn about each step required to demonstrate safety and effectiveness, ensuring compliance and facilitating market entry.
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Ultimate Guide to Clinical Data Management in MedTech
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In this guide, we delve into best practices for collecting, managing, and analyzing clinical data in the MedTech industry, including strategies to ensure data integrity and regulatory compliance throughout the product lifecycle.
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How to Carry Out PMCF Activities According to EU MDR
![How to Carry Out PMCF Activities According to EU MDR]()
This piece outlines the requirements for Post-Market Clinical Follow-up (PMCF) under the European Union Medical Device Regulation (EU MDR). You'll learn how to effectively plan and execute PMCF activities to maintain compliance and ensure ongoing device safety and performance.
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How to Use the Turtle Diagram for Better Internal Audits
![How to Use the Turtle Diagram for Better Internal Audits]()
This article introduces the turtle diagram as a tool to enhance the efficiency and effectiveness of internal audits. You'll learn how to apply this method to systematically assess processes and identify areas for improvement.
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How to Take Control of Training Management and Stay Compliant with ISO 13485:2016 and Part 820.25
![How to Take Control of Training Management and Stay Compliant with ISO 134852016 and Part 820.25]()
Here, we examine the training management requirements outlined in ISO 13485:2016 and FDA's Part 820.25. You'll gain insights into developing compliant training programs that ensure personnel competence and regulatory adherence.
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Ultimate Guide to In Vitro Diagnostic (IVD) Devices
![Ultimate Guide to In Vitro Diagnostic (IVD) Devices]()
This comprehensive guide explores the regulatory landscape, classification, and development processes for In Vitro Diagnostic (IVD) devices, as well as the unique considerations and compliance requirements specific to IVD products.
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MDCG 2024-5: Guidance on the Investigator’s Brochure Explained
![MDCG 2024-5 Guidance on the Investigator’s Brochure Explained]()
This article breaks down the Medical Device Coordination Group's (MDCG) guidance on compiling an Investigator’s Brochure for clinical investigations. You'll learn about the essential components and regulatory expectations for this critical document.
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FDA’s PMA Supplements and Amendments: When and How to Use Each
![FDA’s PMA Supplements and Amendments When and How to Use Each]()
This piece clarifies the distinctions between PMA supplements and amendments in the FDA approval process, explaining when and how to appropriately utilize each to manage changes in your Class III medical device submissions.
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BONUS RESOURCES: Click here to download a free content bundle with our top eBooks, tools, and on-demand webinars from 2024.
Top 10 Webinars
Our free training webinars help medical device professionals keep up with industry best practices, navigate regulatory changes, and stay compliant. Here are our most watched webinars of 2024:
QMSR Final Rule: Meeting FDA’s New Requirements
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This webinar discusses the FDA's transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR), aligning more closely with ISO 13485 standards. You'll learn how to adjust your systems to meet these new regulatory demands.
Access the free on-demand webinar →
Insights from TÜV SÜD and Greenlight Guru on the Requirements of PMCF under the MDR 2017/745
![Insights from TÜV SÜD and Greenlight Guru on the Requirements of PMCF under the MDR 2017745]()
This session provides expert perspectives on Post-Market Clinical Follow-up (PMCF) requirements under the EU MDR 2017/745. You'll gain practical guidance on implementing PMCF activities to maintain compliance and ensure device safety.
Access the free on-demand webinar here →
How to Best Prepare for FDA QMSR
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This webinar offers strategies for transitioning to the FDA's new QMSR framework. Learn the key distinctions between QMSR and ISO 13485 and receive actionable steps to prepare your organization for compliance.
Access the free on-demand webinar →
Demystifying FDA’s Pre-Market Final Guidance
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This session clarifies the FDA's final guidance on medical device cybersecurity, emphasizing risk management throughout the product lifecycle and offering guidance on submission expectations and cybersecurity.
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Key Expectations for ISO 14971 Compliance with Implementation of QMSR
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Here, we explore integrating ISO 14971 risk management principles within the new QMSR framework. You'll discover best practices for designing risk processes that meet regulatory expectations and avoid common pitfalls.
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Global UDI Updates: Navigating EUDAMED Changes & Health Authority Trends
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This session provides updates on global Unique Device Identification (UDI) regulations, focusing on EUDAMED amendments and trends from various health authorities. Viewers will gain valuable insights into developing a practical UDI strategy for product data submissions.
Access the free on-demand webinar →
eSTAR 5.0: Are You Ready?
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This webinar examines the FDA's eSTAR 5.0 platform, highlighting changes to cybersecurity, biocompatibility, and clinical data requirements. You'll receive guidance on navigating the platform for successful 510(k), De Novo, or PMA submissions.
Access the free on-demand webinar →
IEC 62366-1 Essentials: Elevating User Safety in Medical Devices
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In this webinar, we delve into IEC 62366-1, focusing on enhancing user safety and device usability, as well as explaining how to implement the standard effectively to improve medical device design and reduce use errors.
Access the free on-demand webinar →
Mastering the Design Transfer Process
![Mastering the Design Transfer Process]()
This webinar addresses the critical phase of transferring medical device design to manufacturing. You'll explore best practices for ensuring a smooth transition, proper documentation, and alignment between design specifications and production needs.
Access the free on-demand webinar →
Live Q&A with FDA: Cybersecurity Premarket Guidance
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This interactive session featured FDA representatives discussing the final guidance on medical device cybersecurity. Check out what questions your industry peers had around complying with the final guidance on cybersecurity in MedTech.
Access the free on-demand webinar →
BONUS RESOURCES: Click here to download a free content bundle with our top eBooks, tools, and on-demand webinars from 2024.
Top 5 Global Medical Device Podcast Episodes
The Global Medical Device Podcast 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.
Fundamentals of Quality & Regulatory
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In this episode, we explore quality and regulatory roles in the medical device industry with Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting, highlighting proactive quality management, project management skills, and effective communication.
Listen to the full episode →
How Artificial Intelligence is Impacting the MedTech Industry
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In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare.
Listen to the full episode here →
The Evolving Landscape of AI in MedTech
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In this insightful episode, Eric Henry and Etienne Nichols delve into the evolving landscape of AI in MedTech, focusing on regulatory compliance and the future of AI in medical devices.
Listen to the full episode here →
Becoming a MedTech Regulatory Affairs Professional
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In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices.
Listen to the full episode here →
Project Management in MedTech
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This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector.
Listen to the full episode here →
BONUS RESOURCES: Click here to download a free content bundle with our top eBooks, tools, and on-demand webinars from 2024.
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