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2023 was a busy and exciting year here at Greenlight Guru. Over the past 12 months, we’ve been listening closely to our customers, innovating our products, and winning industry accolades along the way.
What does that look like? Well, in 2023, we:
And much, much more! If you want to see the rest, check out our 2023 Year in Review blog post to get the full picture of what we were up to in 2023.
One thing that isn’t new this year, however, is our commitment to putting out the most insightful, informative, and comprehensive content in the MedTech industry. We write, record, and host an enormous amount of content for you throughout the year, which is why we’ve taken the time to look back, find our most popular content, and present it here for you.
There’s something in this list for everyone, so check it out and enjoy!
BONUS RESOURCES: Click here to download a free content bundle with our top eBooks, tools, and on-demand webinars from 2023.
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.
Ultimate Guide to Postmarket Surveillance of Medical Devices
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Comprehensive overview of postmarket surveillance (PMS) of medical devices, covering the different regulations and providing best practices and tips for carrying out PMS activities.
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Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained
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Medical device clinical trials can happen at different points in a device lifecycle. This blog post covers what you need to know about study types and regulatory pathways.
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Process Verification vs Process Validation: What’s the Difference?
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A look at what process verification and process validation refer to, and when you should use each of them in medical device manufacturing.
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Can dFMEA and ISO 14971 Co-Exist in Medical Device Risk Management?
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dFMEA and ISO 14971 offer different approaches to medical device risk management, but they can be used together. This article explains how to do it.
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Ultimate Guide to ISO 14155:2020 Compliant Clinical Investigations
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Become familiar with ISO 14155:2020 in this comprehensive guide, so you can conduct a well-executed clinical investigation for your medical device that yields optimal results.
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FDA Human Factors Guidance Draft: What Medical Device Manufacturers Need to Know
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Explaining the FDA human factors guidance draft to help medical device companies understand the regulatory guidelines and how it could impact their business.
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Top 30 MDCG Guidance Documents for Medical Device Companies
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Use this list of the top 30 MDCG guidance documents for medical device companies to find answers to some of the most-asked questions about EU MDR & IVDR.
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3 Types of QMS Audits (Plus 3 Tips to Prepare for Them)
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A QMS audit doesn’t have to be an ordeal. This blog explains how to prepare for your next external or internal audit/inspection.
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CSV vs. CSA: Exploring FDA’s New Software Validation Approach
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Computer software assurance is the new approach to software validation in MedTech. This blog post explains how it differs from computer system validation.
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Everything You Need to Know about Electronic Data Capture (EDC) Systems
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Electronic data capture (EDC) systems are becoming more and more popular. Learn what exactly an EDC is and how to collect & manage clinical data for MedTech in this blog post.
Read the full blog post →
BONUS RESOURCES: Click here to download a free content bundle with our top eBooks, tools, and on-demand webinars from 2023.
Top 10 Webinars
Our free training webinars help medical device professionals keep up with industry best practices, navigate regulatory changes, and achieve True Quality.
QSR to QMSR: The Rewrite of 21 CFR Part 820 & Key Considerations for FDA Compliance
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FDA regulatory expert Eric Henry provides an overview of the QMSR proposed rule, explains next steps in the rule-making and implementation process, and covers important considerations for medical device manufacturers.
Access the free on-demand webinar →
Demonstrating Conformity to General Safety and Performance Requirements (GSPR) under MDR
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This webinar provides valuable insights and actionable tips on how to demonstrate compliance to the EU’s Medical Device Regulation (MDR) 2017/745 General Safety and Performance Requirements (GSPR).
Access the free on-demand webinar here →
Alternatives to PMCF Clinical Investigations
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Gain insights into alternatives to PMCF clinical investigations and learn ways to accommodate clinical data for compliance with the PMCF requirements under the EU MDR.
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How to Create Your DHF/TF & RMF for a Hardware or Software Medical Device
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A "how to" for DHF/TF and RMF creation for both SaMD and hardware devices, expanding on the key differences between hardware and software Technical File and Risk Documentation, with best practices for achieving compliance for each.
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Preparing Your Technical Documentation under MDR: Proven Tips & Techniques
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Learn techniques and tips to prepare your technical documentation per Annex II and Annex III and how to respond to your Notified Body, as well as get updates on the latest EU news and other relevant regulatory authorities.
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How to Use Clinical Data for Medical Device Submissions in both EU & US
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This webinar offers valuable insights on how medical device companies can optimize their clinical strategy for entering multiple markets.
Access the free on-demand webinar →
Developing IEC 62304 Compliant Software: Proven Tips & Best Practices
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Gain the knowledge, skills, and strategies necessary to successfully implement IEC 62304, ensuring regulatory compliance while developing superior medical device software.
Access the free on-demand webinar →
MDR by the Numbers: Leveraging New Data for Implementation Planning
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Research findings from recent MDCG guidance, industry and Notified Body surveys, and personal stakeholder interviews on first hand experiences with implementation with a goal to bring advice on the process to the forefront.
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Pre-Market Medical Device Studies and GCP - Strategies for Success
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Learn what the main requirements are for Good Clinical Practice (GCP), strategies for successfully fulfilling these requirements, and why it is so important for medical device studies.
Access the free on-demand webinar →
Complaint Handling: How to Avoid the #3 Most Cited Reason for 483 Observations
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Learn best practices for effective complaint handling to avoid timely and costly mistakes as well as creative ways to use complaint handling to your advantage.
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 2023.
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.
FDA Guidance on Artificial Intelligence (AI) in Medical Devices
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In this episode we speak with Mike Drues about artificial intelligence in medical devices, the history of this type of technology in the medical device field, and what FDA's guidance means and doesn't mean.
Listen to the full episode →
Avoiding Potential Issues with your 510(k) Submission
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In this episode we talk to Mike Drues about how to approach a 510(k) submission if your predicate had a recall, how to develop products that are safer and more effective, and the importance of tracing the genealogy of your predicate.
Listen to the full episode here →
Leaning into Lean Documentation
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In this episode we talk with Steve Gompertz about the most important parts of a QMS, what differentiates a good QMS from a bad one, and how to prove ROI on a QMS.
Listen to the full episode here →
Building Your Design Controls (and Pitfalls to Avoid)
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In this episode we talk to Tom Rish about the differences between user needs and design inputs and the pitfalls companies get into when building design controls.
Listen to the full episode here →
Cybersecurity and the Future of MedTech
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In this episode we discuss the new cybersecurity guidelines from FDA, what the agency can and can’t say about it, and what kinds of deficiencies medical device manufacturers can expect in the future because of the new legislation.
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 2023.
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