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Medical Device Classification Guide - How To Determine Your Device Class - Featured Image

Medical Device Classification Guide - How To Determine Your Device Class

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

Top 10 Most Popular Greenlight Guru Posts of 2019

Thank you for helping make 2019 another big and exciting year for Greenlight Guru!
Navigating the Twists and Turns of Change Management for Medical Devices - Featured Image

Navigating the Twists and Turns of Change Management for Medical Devices

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? - Featured Image

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

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 - Featured Image

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

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 - Featured Image

State of Medical Device Product Development and Quality Management Report 2020

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? - Featured Image

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

Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...
Definitive Guide to Change Management for Medical Devices - Featured Image

Definitive Guide to Change Management for Medical Devices

Preparing for EU MDR - Featured Image

Preparing for EU MDR

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 - Featured Image

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

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) - Featured Image

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

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

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

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

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