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State of Medical Device Product Development and Quality Management Report 2020 - Featured Image

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? - Featured Image

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 - Featured Image

Definitive Guide to Change Management for Medical Devices

By Jon Speer on November 17, 2019
Preparing for EU MDR - Featured Image

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 - Featured Image

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) - Featured Image

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? - Featured Image

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...
Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents - Featured Image

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

By Nick Tippmann on October 2, 2019
If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...
Why Design Verification Matters in Medical Device Design and Development - Featured Image

Why Design Verification Matters in Medical Device Design and Development

By Nick Tippmann on September 11, 2019
Design verification can be a difficult stage for medical device companies to carry out effectively. ...
Career Tips for QA/RA Professionals in the Medical Device Industry - Featured Image

Career Tips for QA/RA Professionals in the Medical Device Industry

By Nick Tippmann on August 28, 2019
Medical device quality and regulatory professionals face changes, challenges, requirements, standard...
Right-sizing your QMS - Featured Image

Right-sizing your QMS

By Nick Tippmann on August 21, 2019
Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of...
How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing - Featured Image

How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing

By David Amor on August 18, 2019
When asked whether he hires consultants to help him make investment decisions in the MedTech space, ...

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