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

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 ...

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...

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 ...

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...

Definitive Guide to Change Management for Medical Devices

By Jon Speer on November 17, 2019

Preparing for EU MDR

By Nick Tippmann on November 13, 2019

Do you have a regulatory strategy to help your company prepare for the new European Medical Device R...

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

By Nick Tippmann on November 6, 2019

Quality Assurance and Regulatory Affairs (QA/RA) professionals need to keep their finger on the puls...

The Ultimate Guide to the EU MDR General Safety and Performance Requirements (GSPR)

By James Gianoutsos and Rod Beuzeval on October 20, 2019

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

By Nick Tippmann on October 16, 2019

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devi...

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