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

Medical Device Biocompatibility 101

By Erica Loring on November 8, 2020

Medical device biocompatibility can be confusing, challenging, even frustrating for device professio...

Why Biocompatibility Should be Addressed by Every Medical Device Company

By Nick Tippmann on November 4, 2020

Should your medical device company address biocompatibility? The short answer is, yes. Every single ...

How to Write a Nonconformance Report

By Barret Mueller on October 4, 2020

Nonconformance is a word no quality manager wants to hear.

Addressing Clinical Trial Challenges & Concerns during COVID-19

By Nick Tippmann on July 29, 2020

The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst...

How to Validate Cloud-based Software Tools

By The RND Group on June 21, 2020

Do you remember what computing tools you were using in 2002? I would guess, if you were old enough t...

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

By Nick Tippmann on June 17, 2020

Are you discouraged by all of the negative news and sad stories about COVID-19? Let's shift the focu...

The Beginner's Guide to Design Verification and Design Validation for Medical Devices

By Jesseca Lyons on June 12, 2020

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

How Being Strategic During A Career Transition Can Yield The Best Opportunities

By Nick Tippmann on June 10, 2020

There is a spectrum of feelings someone may experience in the midst of a career transition. For some...

How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends

By Jon Speer on May 3, 2020

Medical device companies are among the most important players in the world’s response to COVID-19.

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

By Tommy Cooper on April 19, 2020

A common dilemma for early stage medical device companies is their lack of expertise in medical devi...

How Software Architecture Enables Faster Release of New Clinical Tests to the Market

By The RND Group on April 12, 2020

The ultimate goal of developing a medical device is to receive FDA approval and to be able to releas...

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...

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