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

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

By Nick Tippmann on March 16, 2022

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the in...

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

By Jon Speer on September 13, 2021

So you need to make a change to your medical device, what now?

Tips for Running Better Management Reviews

By Nick Tippmann on July 19, 2021

How efficient are your management reviews? Could improvements be made? It might be time to reevaluat...

Meet a Guru: Ryan Behringer

By Nick Tippmann on July 14, 2021

Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device com...

Choosing and Managing Your Medical Device Suppliers

By Sara Adams on July 9, 2021

Managing your medical device suppliers is a core responsibility of manufacturers.

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

By Jon Speer on May 28, 2021

Would things be simpler in the medical device regulatory space if there was global harmonization acr...

Meet a Guru: Sara Adams

By Nick Tippmann on March 18, 2021

One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical d...

Everything you Need to Know about SaMD from an FDA Perspective

By Nick Tippmann on March 1, 2021

Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are i...

Preparing for Remote and On-Site Inspections and Audits

By Nick Tippmann on February 24, 2021

How can medical device companies be better prepared for remote and on-site inspections and audits? P...

How does EU MDR impact your Quality Management System?

By Nick Tippmann on February 22, 2021

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challe...

5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes

By Taylor Brown on February 14, 2021

Your internal quality audits should be much more than a “checkbox” requirement on your compliance to...

How Does a Medical Device Quality Management System Differ from other QMS Tools?

By Jon Speer on January 26, 2021

Establishing a more efficient and effective quality management system (QMS) has been a recurring que...

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