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

What are the Changes to ISO 14971:2019 & TR 24971?

By Jon Speer on April 12, 2020

Proper risk management is a key process throughout the entire life cycle of a medical device. This i...

COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health

By Jon Speer on April 5, 2020

COVID-19 has thrown the medical community into a frenzy. Hospitals are struggling as the disease spr...

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

By Jon Speer on March 29, 2020

Throughout 2020, the medical device industry will see significant changes take flight. Among the big...

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

By Jon Speer on March 22, 2020

With the deadline for compliance with the EU MDR just around the corner, big changes are being made ...

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

By Nick Tippmann on February 19, 2020

Regulatory is a big deal for medical device companies. Whether it’s a startup or established busines...

4 Parts to Interviewing Candidates for Medical Device Roles

By Nick Tippmann on February 12, 2020

Are you looking to hire medical device professionals? Or, are you a professional seeking new job opp...

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

By Taylor Brown on February 9, 2020

As leaders of medical device companies, our goal is always to create devices that are safe and effec...

5 Tips for Hiring Medical Device Advisors

By Nick Tippmann on February 5, 2020

Everybody seeks advice and opinions from others from time to time, even those in the medical device ...

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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...

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...

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