Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

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...

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.

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 ...

How to Solve the Medtech Value Equation with Quality Data

By Nick Tippmann on December 4, 2019

Which medical technology, product, or device are you actively focused on bringing to market that wil...

Why Supplier Quality Management Is So Important

By Nick Tippmann on November 27, 2019

Effectively managing suppliers, vendors, consultants, and other third party entities that provide pr...

State of Medical Device Product Development and Quality Management Report 2020

By Jon Speer on November 25, 2019

Greenlight Guru, the only medical device quality management system (MD QMS) software platform, today...

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

By Nick Tippmann on November 20, 2019

Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...

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