Most Popular Medical Device Content in 2022

“One heartbeat led us here.”

Throughout 2022, this has been our signature rallying cry. Sure, it’s got a nice ring to it, and it doesn’t look too bad on a t-shirt either. But this statement is so much more than a slogan. It’s a reminder of why we’re here, of the singular pulse that brings us together. 

At Greenlight Guru, that heartbeat is what drives our mission to improve the quality of life for medical device innovators and their users.

We saw that heart grow three times as large in 2022, as we announced the acquisitions of three world-class companies from across the global MedTech space: SMART-TRIAL - now Greenlight Guru Clinical, the maker of the first and only Electronic Data Capture (EDC) platform designed for medical devices and diagnostics, CanvasGT, a software company enabling iterative MedTech innovation and evolutionary design process, and Vertex Intelligence, a data science company providing groundbreaking artificial intelligence and machine learning solutions. 

As the capabilities of Greenlight Guru’s leading software platform in the medical device industry continued to grow, so too did our product offerings. In 2022, we launched Greenlight Guru Products, a product management software built for MedTech.

These kind of revolutions to our software also led to accolades from G2, and we are proud to once again be ranked the #1 QMS and Medical QMS after holding that top ranking throughout 2022 and have been a leading QMS for seventeen consecutive quarters, based exclusively on the voice of our customers.

And who could forget True Quality 2022? Our first industry conference had over 250 attendees in San Diego and featured keynote speakers like healthcare legend Manny Villafana, founder of St. Jude Medical and the first lithium-powered pacemaker. We also welcomed 6,870 total registrants for the three Virtual Summits we hosted this year, with featured speakers from Notified Bodies, FDA, ISO Working Groups, and more. 

We also doubled down on our commitment to providing customers with quality by earning both ISO 9001 and ISO 27001 certifications. This enormous achievement in both quality management and information security management was a company-wide effort, with contributions made across all departments. This is an output of the culture we’ve built at Greenlight Guru, one which has landed us spots on the lists of 2022 Inc. Best Workplaces and Forbes’s list of the Midwest’s Best Enterprise Software Companies.

And just for good measure, we launched the MedTech Excellence Community, which welcomed 850+ MedTech professionals. We also saw Greenlight Guru Academy continue its high rate of growth with nearly 17,000 learners enrolled in over 38,000 courses in 2022.

And as we neared the end of 2022, we were able to celebrate one of the greatest company milestones Greenlight Guru has achieved, surpassing 1,000 medical device customers.

In a way, all of these milestones across 2022 were part of the same pulse from one heartbeat that led us here—and that’s all thanks to you. Thank you for letting us play a part in the life changing work each and every one of you do.

As a toast to the banner year that was 2022 at Greenlight Guru, we’ve combed through nearly 300 pieces of new content published this year to bring you the crowd favorites from our blog, podcast, webinar, and downloadable resources:

BONUS RESOURCES: Click here to download a free content bundle with our top eBooks, checklists/templates and on-demand webinars from 2022.

Top 10 Greenlight Guru Medical Device Blog Posts of 2022

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.

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

Explaining the Periodic Safety Update Report (PSUR), distinguishing it from the post-market surveillance report (PMS), and offering guidance on what should go into a compliant PSUR.

Read the full blog post here →

Ultimate Guide to Software as a Medical Device (SaMD)

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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Everything You Need to Know About Root Cause Analysis

Root cause analysis is an essential component of your quality event processes, like CAPA, complaint, and nonconformance. Learn about the methods you should use and tips for using them effectively.

Read the full blog post here →

Ultimate Guide to UDI for Medical Devices

A comprehensive guide to UDI (Unique Device Identification) for medical device manufacturers.

Read the full blog post here →

What is the Best Way to Structure a Risk Management File?

Medical device risk management files are a master document for all risk-related activities. Are you sure you're organizing and tracking these files in the best way?

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Ultimate Guide to Device Class Requirements under EU MDR

A comprehensive guide to medical device class requirements under EU MDR with detailed instructions on how to classify and categorize your device according to the European regulation.

Read the full blog post here →

QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

Explaining the QMSR (Quality Management System Regulation) proposed by FDA to harmonize its Quality System Regulation (QSR) with ISO 13485:2016.

Read the full blog post here →

Ultimate Guide to Clinical Evaluation of a Medical Device in the EU

Comprehensive guide to help manufacturers understand the essentials of clinical evaluation for medical devices in the European Union (EU).

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Understanding the Quality Control Process in Medical Device Manufacturing

Explaining quality control processes in the medical device industry with actionable steps for companies to use when evaluating their quality control process.

Read the full blog post here →

Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities

Your Post-Market Clinical Follow Up (PMCF) is an essential part of your post-market surveillance activities. Learn more about how to plan and carry out your PMCF.

Read the full blog post here →

BONUS RESOURCES: Click here to download a free content bundle with our top eBooks, checklists/templates and on-demand webinars from 2022.

Top 5 Greenlight Guru Webinars
 of 2022

Our free training webinars help medical device professionals keep up with industry best practices, navigate regulatory changes, and achieve True Quality.

UDI Product Data and EUDAMED, Get Onboard!

This webinar covers suggested best practices concerning EUDAMED preparation, what we have learned via testing and a Q&A session about medical device registration scenarios, data elements and requirements. 

Access the free on-demand webinar here →

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

This webinar explains what medical device companies need to know about MDR and Tech File changes by expanding on the new MDR requirements and providing key insights and guidance.

Access the free on-demand webinar here →

Usability Testing: Why Can’t We Get it Right?

This webinar takes a critical look at the way medical device companies do usability testing today to understand how we can do it better while still ticking the regulatory boxes.

Access the free on-demand webinar here →

How to Survive an FDA Inspection

This webinar covers preventative actions that medical device companies can take to minimize the possibility of receiving a 483, which in some cases could result in a product seizure.

Access the free on-demand webinar here →

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

This webinar explains the FDA letter-to-file path for medical device companies and demonstrates the right way to prepare a LTF.

Access the free on-demand webinar here →

BONUS RESOURCES: Click here to download a free content bundle with our top eBooks, checklists/templates and on-demand webinars from 2022.

Top 5 Global Medical Device Podcast Episodes of 2022

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.

Understanding the UDI System for Medical Devices

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz about the key points every medical device professional should know about the UDI system.

Listen to the full episode here →

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

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Shannon Hoste about the connection between human factors, risk management, and product development.

Listen to the full episode here →

How to Select a Contract Manufacturer

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mark Rutkiewicz about his winning formula for selecting and engaging with contract manufacturers in the medical device industry.

Listen to the full episode here →

A Regulatory Gap Analysis of FDA's Systems & Policies

In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues about an ideal regulatory system, providing a gap analysis of regulatory systems and policies to help manufacturers be more proactive rather than take a reactive approach.

Listen to the full episode here →

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

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mike Drues and George Zack about the QSR and ISO 13485 harmonization, and discuss the pros and cons of incorporating a standard not governed by FDA.

Listen to the full episode here →

BONUS RESOURCES: Click here to download a free content bundle with our top eBooks, checklists/templates and on-demand webinars from 2022.

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