Medical Device Quality, Regulatory and Product Development Blog

7 Tips to Comply With FDA 21 CFR Part 11

By Jon Speer on January 15, 2020

When it comes to regulatory compliance for medical device companies, there can be some confusion aro...

5 Steps for Getting your CE Marking with EU MDR Requirements

By Tom Rish on January 12, 2020

It has long been thought that the quickest path to market for medical device manufacturers is to acc...

The Art of Defining Design Inputs And Design Outputs

By Jon Speer on January 8, 2020

Design inputs are the king of medical device product development. If a product that is in the market...

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

By Jon Speer on January 5, 2020

As a medical device company, you are expected to deliver innovative, life-changing medical device(s)...

Medical Device Classification Guide - How To Determine Your Device Class

By Tom Rish on January 2, 2020

What I am about to share with you is a guide to medical device regulatory classification.

Top 10 Most Popular Greenlight Guru Posts of 2019 - Featured Image

Navigating the Twists and Turns of Change Management for Medical Devices

By Nick Tippmann on December 28, 2019

Change is constant… Especially in the medical device industry. Medical device change management can ...

Top 40+ Medical Device Conferences To Attend in 2020

By Nick Tippmann on December 20, 2019

Simply attending the right medical device conference can be a game-changer for those who work in the...

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

By Nick Tippmann on December 18, 2019

FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...

3 Pros and Cons to 3D Printing for Medical Devices

By Kayla Matthews on December 15, 2019

3D printing processes — which use digital models to create physical devices out of materials like pl...

5 Myths about QA/RA Recruiting in the Medical Device Industry

By Nick Tippmann on December 11, 2019

Recruiting top, elite quality assurance and regulatory affairs (QA/RA) talent in the medical device ...

Greenlight Guru Announces Enhanced Change Management Capabilities

By Nick Tippmann on December 9, 2019

Medical device quality management system (MDQMS) improves traceability and efficiency associated wit...

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