Medical Device Quality, Regulatory and Product Development Blog

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

By Edwin Bills, ASQ Fellow, RAC on April 1, 2019

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i] As ...

Case Study: Centese ditches paper-based QMS AND achieves FDA 510(k) clearance

By Nick Tippmann on March 29, 2019

For many early-stage medical device companies, the default option when implementing a quality manage...

Case Study: How Innovere Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device eQMS

By Nick Tippmann on March 28, 2019

Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare...

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

By Nick Tippmann on March 27, 2019

FDA recently released a new guidance document titled, Safety and Performance Based Pathway, which pe...

Why Document Control Matters To Medical Device Companies

By Jon Speer on March 24, 2019

As medical device professionals, we share a common goal of producing safe and effective medical devi...

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

By Jon Speer on March 17, 2019

A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...

The Greenlight Guru True Quality Roadshow: Atlanta Recap

By Nick Tippmann on March 15, 2019

We’re back from the peach state and an evening at The Gathering Spot in Atlanta for The Greenlight G...

Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process With Greenlight Guru

By Nick Tippmann on March 13, 2019

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...

Case Study: How Greenlight Guru is laying the foundation for success at Amnion Life

By Nick Tippmann on March 12, 2019

The majority of medical device companies operate on an emphasis of high quality outcomes and scalabi...

Why Flexible Design Reviews Matter for Medical Device Product Development

By Jon Speer on March 10, 2019

It is my humble and expert opinion that the medical device industry has the most significant impact ...

Nonbinding Feedback is a New Guidance You Should Know About

By Nick Tippmann on March 8, 2019

FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Ins...

Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams

By Nick Tippmann on March 5, 2019

Medical device quality management system debuts flexible design review capabilities for devices with...

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