Thank you for helping make 2018 another big and exciting year for Greenlight Guru!
We even rolled out a new product overview video that you can check out below if you haven't already.
What was your favorite highlight of 2018? Let us know in the comments section or send us a note!
Below is our annual list of the top most popular content pieces we published in 2018.
Top 10 BLOGS of 2018
#10: Understanding the New Requirements for QMS Software Validation in ISO 13485:2016
As leading experts in the QMS software space, we wanted to provide a detailed overview of the new requirements for QMS software validation in ISO 13485:2016.
We also provide tips and best practices to make sure you'll be ready to ace your transition audit.
Understanding the New Requirements for QMS Software Validation in ISO 13485:2016 provides everything you need to know about what's included in the new requirements for quality system software validation in ISO 13485:2016.
#9: 21 CFR Part 11: A Complete Guide
Become an expert on FDA's regulatory electronic requirements for a medical device QMS in 21 CFR Part 11: A Complete Guide.
In this comprehensive guide, you'll learn about each section of 21 CFR Part 11, through a clear explanation of what the requirements actually mean and the most important points for you to know as a medical device professional.
#8: ISO 13485 - Ultimate Guide to Quality Management Systems (QMS) for Medical Devices
Everything you want and need to know about ISO 13485:2016 can be found in ISO 13485 - Ultimate Guide to Quality Management Systems (QMS) for Medical Devices.
Immerse yourself in our most comprehensive guide to date and gain significant value into every aspect of your QMS. Consider this your blueprint to help you design a well built, interconnected system--a quality system that allows you to focus on true quality vs. only compliance.
#7: Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016
Change is constant in the medical device industry. Having a deep understanding of the regulatory landscape that can be found in Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016 will only benefit your company.
This ebook provides an overview into some of the major changes happening in our industry right now, and offers medical device professionals helpful recommendations to consider when managing these changes.
#6: Understanding the 5 Phases of Medical Device Development
Whether you have an idea for new medical device, are in the final stage of bringing your device to market, or somewhere in between, it's critical that you understand the different phases of the development cycle.
Make sure you know what the developmental process entails and how to best navigate it in our blog about Understanding the 5 Phases of Medical Device Development.
#5: 5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)
No one can predict the future. But there are a few key indicators we can use to give our most educated guesses.
One thing is for sure--it never hurts to be prepared. That's the goal of this content piece.
Find out how accurate our industry predictions were for 2018 in our highly anticipated annual content piece, 5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare).
#4: Ultimate List of Medical Device Incubators and Accelerators (50+)
To help connect you with the resources you need for success, we’ve put together a master list of the best healthcare accelerators and incubators for new medical device companies in our Ultimate List of Medical Device Incubators and Accelerators (50+).
#3: FDA 510(k) Submission: A Step-By-Step Guide on How to Prepare yours
Feeling a little lost as you start to compile your first 510(k) submission?
FDA 510(k) Submission: A Step-By-Step Guide on How to Prepare yours aims to put the requirements in easy-to-understand terms and includes some helpful, actionable and practical tips you can begin to implement immediately.
The goal of this informative guide is to provide you step-by-step guidance through each part of the FDA 510(k) submission process and help improve your time to market.
#2: Medical Device Companies - Top 100 in 2018
Have you ever wondered about which medical device companies fall into the top tier from a global scale?
What does it take to join this premier group of industry leaders? There's not one magic silver bullet--there's actually many.
Check out who made the cut and what it takes to make it to the top in our exclusive content piece, Medical Device Companies - Top 100 in 2018 (Free Chart).
#1: The Ultimate Guide To Design Controls For Medical Device Companies
Design controls demonstrate our medical devices are safe, effective, and meet the indications for use. They are the building blocks and arguably the most important process to manage for device makers.
The Ultimate Guide To Design Controls For Medical Device Companies provides valuable insights into what they are, how to address them, and its benefits for your product development efforts.
Top 5 Webinars of 2018
#5: The 510(k) and Substantial Equivalence: Why do so many get it wrong?
Most 510(k)'s are rejected specifically because of substantial equivalence (SE). But what does SE really mean and how do you show it? How do you use not just what the regulation says, but also what it does not say to your advantage?
These questions and more are answered in The 510(k) and Substantial Equivalence: Why do so many get it wrong? presented by Mike Drues of Vascular Sciences.
#4: Bridging User Needs & Design Requirements: Answers are Only as Good as the Questions we Ask!
Is regulatory and quality simply about making sure your design inputs match your user needs, i.e., ticking the boxes? What if your user needs are wrong? Do we need regulation to require us to make sure we are solving the right problems? Asking the right questions?
Regulation is all about the interpretation of words and your ability to defend your interpretation. In Bridging User Needs & Design Requirements: Answers are Only as Good as the Questions we Ask! presented by Michael Drues, Ph.D., participants learn best practices to avoid timely and costly mistakes and creative ways to use the regulation to their advantage!
#3: Standards, Standards, Standards Makes the Medical Device World Go Around
Standards, Standards, Standards Makes the Medical Device World Go Around, introduces you to IMDRF, reviews their upcoming guidance entitled “Optimizing Standards for Regulatory Use," and discusses the role IMDRF and its priorities play in relation to international medical electrical equipment standards in IEC 60601-1 series, proposed IEC 60601 series updates, and significant changes planned for the draft IEC 60601-1 Ed3.2.
#2: 10 Things You Must Know About Updating Your Technical Files to Comply with EU MDR
The new regulation brings significant change, some of the largest coming from what is expected from your technical documentation.
How much remediation will be needed? What steps should you be taking now? What are the new expectations?
In 10 Things You Must Know About Updating Your Technical Files to Comply with EU MDR, presented by Sameer Jaiswal, a PRP Consultant & EU MDR SME, you learn exactly what you need to do with your technical files to comply with the new EU MDR.
#1: Case for Quality four-part Webinar Series
Top-quality medical devices help the FDA better protect and promote public health. And one of the top priorities for FDA's medical devices center is a focus on quality.
The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. This program allows the FDA to recognize device manufacturers that are capable of consistently producing high-quality devices and continuously improving.
Greenlight Guru is partnering with FDA CDRH to help spread the word and promote the Case for Quality initiative and its benefits to the medical device industry.
Case for Quality four-part Webinar Series is presented by FDA Case for Quality Program Manager Cisco Vicenty and presents an overview on lessons learned from pilot program participants.
TOP 5 Podcasts OF 2018
#5: Debunking Premarket Approval (PMA) Myths (and why the PMA path may not be as scary as you think)
When developing a new medical device, do you try to figure out the fastest and simplest way to get your product to market? Do you explore a regulatory path? Or, are you afraid that may kill your idea?
We did some premarket approval (PMA) myth busting and tell you why a PMA path may not be as scary as you think.
#4: Evaluating FDA's "New" Proposed Fast-Track Alternative Approach to the 510(k) Pathway
FDA recently released a guidance draft on a quick path to approval as an alternative to the 510(k).
The question being, is this really anything new?
We talk through this buzz worthy topic to understand what’s different about this fast track and how it might benefit you.
#3: What are the Regulatory Expectations for Software as a Medical Device?
Software as a medical device (SaMD) is a hot topic and regulators are updating requirements and launching new initiatives in response.
This has resulted in a lot of confusion surrounding those regulatory expectations. We explain the how, what, and when you should act if you are a SaMD company.
#2: What Substantial Equivalence Means as it Applies to 510(k)'s & Why it's Important
Do you have a firm grasp of what substantial equivalence means in regards to the 510(k)?
We took a close look at how companies demonstrate substantial equivalence to define what it means and how it relates and applies to the 510(k) clearance pathway.
#1: Tips, Tricks & Best Practices for Complying with ISO 13485:2016
When it comes to ISO 13485:2016, are you scrambling to meet requirements?
We came up with our best tips and tricks for compliance with ISO 13485:2016 to help companies gain certification before the 2019 deadline.
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