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

By Jon Speer on July 12, 2020

Many device professionals in small to medium-sized businesses (SMB) still use legacy systems to supp...

By Nick Tippmann on July 8, 2020

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...

By Jon Speer on July 5, 2020

Some companies in the medical device industry show resistance to digital technology, preferring to u...

By Jon Speer on June 28, 2020

What is the expected process you should follow for your medical device design planning and controls?

By Jesseca Lyons on June 12, 2020

When your medical device product development project gets to Design Verification and Design Validati...

By Jon Speer on March 29, 2020

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

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 ...

By Jon Speer on April 9, 2018

If you’re using a paper-based system to manage your design history file (DHF), it can raise several ...

By Jon Speer on August 6, 2015

Medical device companies MUST have established risk management processes that comply with ISO 14971.

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