At Greenlight Guru, we’ll never forget 2021. It was a big year of growth for us, our customers, and the medical device industry as a whole.
As we move into 2022, here's a snapshot of what happened over the past year:
One defining moment was when Greenlight Guru received a $120 million investment from JMI Equity, a software-focused growth equity firm, a partnership allowing us to accelerate product development, expand our capabilities, and support significant global growth.
Customers can look forward to more game-changing tools like Intelligent Document Management powered by HaloSM, our AI and machine learning recommendation engine.
We also launched Guru Assist, an on-demand lifeline to our in-house medical device experts, where customers access the knowledge and expertise of our Gurus when and where they need it. Maybe that’s why we’ve been ranked the #1 QMS software on G2 for the third year in a row. Check out our newest case studies if you want to hear why our customers keep putting us in the leader’s position.
2021 also saw the launch of Greenlight Guru Academy, a place for medical device professionals to learn new skills and industry knowledge, and get comprehensive certifications for training and regulatory requirements. The most popular free course this year? Our Overview of Design Controls. And the most popular certification was our Introduction to Design Controls for Medical Devices.
We hosted four True Quality Summit Series events with over 12,000 registrants and speakers from organizations like TUV SUD, ISO Working Groups, and the NIH. These events covered vital topics like Risk Management, Get to Market strategies, Raising Capital, and our largest event on MDR/IVDR, which had over 6500 registrants, 20 sessions, and 20+ speakers. And let’s not forget how special Green Carpet Day was for us and our customers.
Of course, none of this happens without our team. That’s why we continued our investment in company-wide mindset training to promote health and wellness (we even found out who can get the best sleep).
Maybe it’s why Greenlight Guru was ranked one of the best places to work in the country. Check out our current job openings!
We also published 180+ new pieces of content this past year. If you didn’t catch them all, we’ve put together this list of our most popular content from 2021. We hope you enjoy consuming them as much as we did creating them.
Wishing you and yours the very best in 2022!
Top 10 GREENLIGHT GURU MEDICAL DEVICE BLOg Posts of 2021
Definitive Guide to Change Management for Medical Devices
An in-depth definitive guide on change management best practices for medical device companies to help manufacturers understand and manage changes to documents, products, processes and more.
Read the full blog post here →
Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?
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This article provides a helpful comparison of the different premarket submission types from FDA, Special 510(k), Abbreviated 510(k), and Traditional 510(k) to help medical device companies determine the best option for their medical device.
Read the full blog post here →
Cybersecurity for Medical Devices: Best Practices from Regulatory Standards
This article covers medical device cybersecurity guidelines from IEC 62304, ISO 14971 and FDA guidance documents, providing a comprehensive summary the industry best practices and current manufacturing standards medical device companies should follow.
Read the full blog post here →
How to Build Medical Device Usability Testing and Validation into Your Quality System
Manufacturers can get an introductory look at medical device usability testing and validation in this blog post that provides step-by-step instructions on how to build these key processes into a quality system.
Read the full blog post here →
What is a Traceability Matrix and How Do I Create One for My Medical Device?
This blog post explains what a traceability matrix is and how medical device professionals can create one within a quality management system environment that is setup to meet regulatory expectations and improve product outcomes.
Read the full blog post here →
How to Approach Corrective Action Requests with Medical Device Suppliers
This article breaks down the finer points of corrective action requests and provides a detailed explanation for medical device manufacturers to understand how to differentiate these from supplier corrective action requests (SCAR).
Read the full blog post here →
How to Structure your Medical Device Technical File
Medical device manufacturers selling into the EU can gain a clear understanding of exactly what is required of a technical file and how to structure one in order to successfully enter the EU marketplace in this actionable article.
Read the full blog post here →
Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered
Questions surrounding the new requirements for Person Responsible for Regulatory Compliance (PRRC) under MDR and IVDR are answered in a series of questions about the roles, responsibilities, and qualifications of a PRRC in this blog post.
Read the full blog post here →
IQ, OQ, PQ: A Quick Guide to Process Validation
This article provides medical device manufacturers with an easy to understand overview of process validation and the three phases it consists of: installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ).
Read the full blog post here →
Ultimate List of ISO Standards for Medical Devices
A comprehensive, easy-to-navigate list of the top fifty ISO standards for medical devices to help manufacturers understand and easily find
and apply up to date regulatory information applicable to their product.
Read the full blog post here →
Top 5 Greenlight Guru Webinars of 2021
Attention ⚠️ ISO 15223-1 4th Ed. is almost here: How to update your medical device labeling to comply with the new requirements
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 ways to easily and effectively transition to compliance with the new requirements.
Access the free on-demand webinar here →
FDA vs. EU Regulatory Pathways: Factors Every Startup Must Consider with Go-to-Market Strategy
A free, in-depth webinar, presented by regulatory experts from the Greenlight Guru Regulatory Advisory Board, comparing and contrasting FDA versus EU regulatory pathways, relative timelines and costs, the importance of clinical data, and other relevant topics.
Access the free on-demand webinar here →
The “New” 510k: How Do You Show Substantial Equivalence Without Using A Predicate?
World-renowned regulatory expert Michael Drues presents an in-depth, interactive webinar covering the “new” safety and performance based pathway (sp510k), an expansion of the abbreviated 510(k) for certain “well understood” devices.
Access the free on-demand webinar here →
Human Factors Engineering: The Worldwide Guide for Medical Device Manufacturers
A highly informative webinar covering the human factors engineering process and how manufacturers can comply with the applicable regulatory requirements of the US, UK, EU, and other international standards.
Access the free on-demand webinar here →
Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device
This actionable webinar presentation offers actionable tips and guidance for manufacturers looking to evaluate whether biocompatibility testing and risk mitigations are necessary when making changes to a medical device.
Access the free on-demand webinar here →
TOP 5 global medical device Podcast episodes OF 2021
Everything you Need to Know about SaMD from an FDA Perspective
In this episode Jon Speer talks to David Pudwill a.k.a. “Mr. Regulatory” discuss all things related to SaMD from the perspective of FDA and how the agency is regulating these emerging medical device technologies.
Listen to the full episode here →
Understanding FDA's New Intended Use Rule and its Implications
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In this episode Jon Speer talks to Mike Drues about FDA’s amendment to its final rule regulations and the implications it has on intended use, manufacturer’s objective intent, and its role with labeling.
Listen to the full episode here →
Explaining the Role of Importer under EU MDR
In this episode Jon Speer and René Van De Zande discuss expectations, criteria, and obligations for importers under EU MDR and how this role should be managed for post-market surveillance, tracking, labeling, translations, and complaints.
Listen to the full episode here →
How does EU MDR impact your Quality Management System?
In this episode Jon Speer talks to Monir El Azzouzi about the ways in which EU MDR impacts a quality management system and best practices medical device companies can follow to maintain compliance with new requirements.
Listen to the full episode here →
Prioritizing Medical Device Reimbursement During Product Development
In this episode Jon Speer talks to Mike Drues about the importance of medical device reimbursement and offers tips listeners can use to build a competitive reimbursement strategy that puts dollars back in the company’s pocket once a device is on the market.
Listen to the full episode here →
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Free Resource Bundle: Most Popular Medical Device Content in 2021
