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Thank you for helping make 2020 another exciting and record-breaking year for Greenlight Guru!

We had so many things to celebrate over this past year... Let’s take a quick look back at some of our biggest accomplishments from 2020:

We released significant enhancements to the Greenlight Guru MDQMS software platform by rolling out a new dedicated Training Management workspace, launching Quality Event Automation which enables high efficiency and consistency across quality processes , and announcing our machine-learning and natural language processing powered technology Visualize that redefines the way manufacturers approach closed-loop traceability.

While our 2021 True Quality Roadshow event was unfortunately cut short due to COVID-19, we were still able to make a far-reaching impact on medical device communities around the world. We hosted our first virtual industry 3-day conference with the True Quality Virtual Summit event which amassed over 5,000 registrants, each of whom gained valuable insights and teachings from presentations by the industry’s leading experts.

Speaking of industry experts, Greenlight Guru's partner channel had a lot to celebrate over the year. We announced a strategic alliance with EMERGO by UL, a global leader in medical device regulatory compliance, as well as solidified additional new partnerships with other top consulting firms to provide companies with an even larger network of trusted industry advisors.

We also conducted our second annual industry benchmark survey and published the revealing insights from our findings in our 2021 State of Medical Device Product Development and Quality management report. You can view and download the full report here at no cost.

From a business standpoint, Greenlight Guru has experienced the highest rate of growth and success in company history. We are celebrating two consecutive years as a G2 market leader in the quality management software category. Our team has grown by more than 50% and we're continuing to add new remote positions on an ongoing basis. Check out the current job openings to see if you or someone you know would be a good fit to join our team.

One of the ways we like to give back to the medical device community is through our free medical device content. The resources we publish are geared around sharing new and innovative ways to deliver safe, effective, True Quality devices to patients. But that's only one part of the equation—it's your company and your device that makes it all come to fruition, so we can meet one shared goal: improving the quality of life. 

On behalf of the entire Greenlight Guru team, we want to say thank you for your ongoing contributions to that mission and for your loyal support and readership. We look forward to continuing to share more valuable content with you in 2021 and beyond.

We hope you enjoy this annual list of our most popular content from 2020. Let us know which content was your favorite from 2020 in the comments section or by sending us a note!

Cheers to an unforgettable 2020—we wish you and your loved ones good fortune and health for the new year!

FREE DOWNLOAD: Click here to access the downloadable content (eBooks, webinar recordings and slides) from all of our top 2020 posts.

 

Top 10 POSTS FROM THE GREENLIGHT GURU MEDICAL DEVICE BLOG IN 2020

 

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

21-cfr-part-820-fda-quality-system-regulation-qsr-medical-devices

In-depth guide covering the requirements of 21 CFR Part 820, FDA's quality system regulation for medical devices, with tips that explain how companies can comply and avoid common pitfalls with each relevant section.

Read the full blog post here →

 

 

The Ultimate Internal Audit Checklist Every Medical Device Company Needs

The Ultimate Internal Audit Checklist Every Medical Device Company Needs

This guide provides the ultimate internal audit checklist that every medical device professional needs to conduct audits with ease and ensure quality system compliance and optimal performance.

 

Read the full blog post here →

 

 

How to Write a Nonconformance Report

How to write a nonconformance report

The key to transforming a nonconformance into an opportunity is how well you can construct your nonconformance report. This article lays out the seven steps to take for writing an effective nonconformance report.

Read the full report here →

 

 

 

Document Control for Medical Device Companies: The Ultimate Guide

UG-document-control-medical-device-companies

An in-depth guide explaining how medical device companies can control documents and improve procedures through proven solutions to common problems and methods for implementing a document management system that enables product and business success.

Read the full blog post here →

 

 

Top 100 Medical Device Acronyms & Terminology You Need to Know

top 100 med device acronyms

A comprehensive list of the top 100 acronyms and terminology used in the medical device industry, with easy to understand definitions and references so you can eliminate the confusion and misinterpretation once and for all.

Read the full blog post here →

 

 

Medical Device Companies - Top 100 in 2020 (Free Chart)

Top 100 Medical Device Companies

A crowd-favorite list of the top 100 medical device companies from around the world that you can reference to develop a broader view of the global medical device marketplace and get to know the biggest players in the industry.

Read the full blog post here →

 

 

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

Best QMS software ebook CTA

This highly valuable buyer's guide compares the best QMS software solutions for medical devices so companies in this niche vertical can make an informed, strategic buying decision when investing in a quality management system.

Read the full blog post here →

 

 

7 Tips to Comply With FDA 21 CFR Part 11

7 Tips to Comply With FDA 21 CFR Part 11

This guide expands on 7 tips for compliance with FDA’s 21 CFR Part 11 by providing clarifying details on common points of confusion with this regulation and how medical device companies can familiarize themselves with the requirements for easy implementation.

Read the full blog post here →

 

 

5 Steps for Getting your CE Marking with EU MDR Requirements

5 steps for getting your CE marking with EU MDR requirementsThis article describes the path to compliance under Europe's medical device regulation by providing 5 key steps medical device companies must take to obtain a CE marking for product distribution into the EU marketplace once the regulation goes into effect in May 2021.

Read the full blog post here →

 

 

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

15 questions QMS software vendors

15 questions you should be asking any prospective QMS software vendor that will help you uncover the necessary information needed to make the best decision on choosing a QMS solution that will help improve your product development and quality activities.

Read the full blog post here →

 

FREE DOWNLOAD: Click here to access all downloadable content (eBooks, webinar recordings and slides) from our top 2020 posts.

 

Top 5 Webinars of 2020

 

How to Implement and Maintain a Modern CAPA System while Avoiding Common Pitfalls

9-17-20 webinar graphicIn this free webinar presented by Jon Speer of Greenlight Guru, participants will learn how to avoid common CAPA pitfalls and proven best practices that will improve your CAPA processes to produce safe and effective devices for end users and in the eyes of regulators.

Access the free on-demand webinar here →

 

 

Beyond Design Controls 101: Following the Regulation vs. Understanding Its Intent

MDrues webinar - design controls 101In this free webinar presented by Mike Drues, PhD of Vascular Sciences, participants are given everything they need to know about design controls and the important distinction between simply following the regulation versus understanding its intent.

Access the free on-demand webinar here →

 

 

Understanding the Medical Device Classification System: Using Classification to your Competitive Advantage

Understanding the Medical Device Classification System: Using Classification to your Competitive AdvantageThis free webinar presented by Mike Drues, PhD of Vascular Sciences covers a key area of focus for companies, device classification; viewers will be given the necessary tools to understand the classification system so you can use it to your strategic advantage.

Access the free on-demand webinar here →

 

 

Insider’s look at the IEC 60601 Amendments: Detailed Guidance from Committee Member Responsible for Changes

L.Eisner 8-27-20 webinar graphic-1This free, in-depth webinar presented by a major contributor to The Amendment Project covers the significant changes of the IEC 60601 Amendments and how medical device manufacturers and consultants can prepare accordingly.

Access the free on-demand webinar here →

 

 

Verification and Testing Strategies for Compliance with ISO 13485:2016, IEC 62304 / 60601 / 82304

K.Rose 8-6-20 webinar promo graphicIn this free webinar Kyle Rose of Rook Quality Systems gives a valuable presentation on the most effective verification and testing strategies device companies can implement for compliance with ISO 13485:2016, IEC 62034 / 60601-1 / 82304-1. 

Access the free on-demand webinar here →

 

FREE DOWNLOAD: Click here to access the downloadable content (eBooks, webinar recordings and slides) from all of our top 2020 posts.

 

TOP 5 global medical device Podcast episodes OF 2020

 

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

Jon Speer & Mike Drues

In this episode Jon Speer (Greenlight Guru) and his guest Mike Drues (Vascular Sciences) discuss the recent FDA report that outlines the FDA CDRH’s 2020 priorities with a couple big ones believed by Mike and Jon to be missing from the list.

Listen to the full episode here →

 

 

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

GMDP-header-isabella-schmitt

Isabella Schmitt (Proxima Clinical Research) joins Jon Speer (Greenlight Guru) to tell medical device companies how they can establish a solid foundation for fundraising and product success through a heightened regulatory focus.

Listen to the full episode here →

 

 

[LIVE] Design Controls, Development & Risk for Software as a Medical Device (SaMD)

GMDP - Live TQR San Jose

This special video recorded episode from The Greenlight Guru True Quality Roadshow features host Tom Rish (Greenlight Guru) and guest Chris DuPont (Galen Data) as the two discuss the design control and development process for software as a medical device (SaMD).

Listen to the full episode here →

 

 

4 Parts to Interviewing Candidates for Medical Device Roles

GMDP-header_mitch-robbins

Episode guest Mitch Robbins (The Anthony Michael Group) joins Jon Speer (Greenlight Guru) on the show to break down the 4 key parts to the medical device candidate interview process and explains the pros and cons of each.

Listen to the full episode here →

 

 

How to Choose the Right FDA Regulatory Pathway for your Device

How to Choose the Right FDA Regulatory Pathway for your Device

Jon Speer (Greenlight Guru) and his guest Mike Drues (Vascular Sciences) cover the details you need to know about each of FDA’s regulatory pathways to bring a medical device to market in the U.S. to help listeners decide which option is best suited for their device.

Listen to the full episode here →

 

FREE DOWNLOAD: Click here to access the downloadable content (eBooks, webinar recordings and slides) from all of our top 2020 posts.

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Looking for an all-in-one QMS solution to advance the success of your in-market devices that can integrate your post-market activities with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →