2025 was an eventful year in the medtech landscape, with plenty of changes happening within the industry.
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 in one place.
There’s something here for everyone, so see what grabs your interest and enjoy!
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.
This post explains how to create a Quality Manual that meets the ISO 13485:2016 standard, emphasizing that the manual serves as the essential navigational table of contents for a company's Quality Management System (QMS).
This article provides 11 essential questions medical device companies should ask QMS software vendors to ensure the solution meets industry-specific needs. The questions focus on regulatory alignment, built-in compliance workflows, and closed-loop traceability.
This post guides medical device companies on how to conform with the General Safety and Performance Requirements (GSPR) of the EU MDR, which is mandatory for placing a device on the EU market. It recommends using a GSPR checklist to demonstrate compliance by referencing applicable harmonized standards.
This resource lists the top 50 Venture Capital firms that actively invest in medical device and life sciences startups. It serves as a guide for young MedTech companies seeking crucial financial backing for product development and market launch.
This post explains how to use a Failure Mode Effects Analysis (FMEA) template as a complement to the broader risk management system required by ISO 14971:2019.
This post reviews the FDA's guidance documents on Artificial Intelligence-Enabled Device Software Functions (AI-DSF), focusing on lifecycle management recommendations and the final rule on Predetermined Change Control Plans (PCCP).
This article details the three key steps for conducting a risk-based supplier assessment in MedTech to ensure a reliable supply chain and regulatory compliance. The steps involve classifying suppliers by risk level and structuring monitoring activities, like audits, according to that risk.
A former FDA investigator offers three key insights for MedTech product development, advising companies to build a strong foundation of regulatory knowledge and align R&D with production for compliant data collection.
This guide explains the new Quality Management System Regulation (QMSR), which harmonizes U.S. FDA 21 CFR Part 820 by incorporating ISO 13485:2016 by reference. It details the few sections of the new Part 820 that retain explicit FDA requirements not fully addressed by the ISO standard.
This post advocates for a "Dynamic Risk Management" approach for software-enabled medical devices, contrasting it with static, spreadsheet-based methods.
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 2025:
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.
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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.
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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.
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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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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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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.
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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.
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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.
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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.
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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.
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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.
Host Etienne Nichols and MedTech founder Olga Chashchina explore how understanding cultural contexts, such as high- versus low-context communication, is essential for successfully managing global teams and improving patient care.
Host Etienne Nichols leads a foundational discussion with Sara Adams and Chris Rush, demystifying the MedTech industry by covering medical device definition, FDA classification, regulatory pathways, and design controls.
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Host Etienne Nichols and Greenlight Guru's Sara Adams review key findings from the 2025 Medical Device Industry Report, providing a strategic outlook on market growth, supply chain complexity, and regulatory changes like the QMSR.
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Host Etienne Nichols and executive coach Lesley Worthington discuss the importance of communication in quality, explaining that true influence comes from making others feel understood, not just being technically correct.
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Host Etienne Nichols is joined by Ashkon Rasooli, who outlines a phased approach to QMS implementation, advising companies to build their system proactively in alignment with product development rather than waiting for regulatory checkpoints.