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

Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster

By Nick Tippmann on January 5, 2021

Customers benefit from expert advice to lower development costs and save time identifying the right ...

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

By Nick Tippmann on December 2, 2020

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device ind...

What Goes into Designing Devices for Military and Emergency Applications?

By Nick Tippmann on November 25, 2020

There’s one niche market within the device industry that rarely gets the attention it deserves: prod...

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.

Quality Assurance vs. Quality Control in the Medical Device Industry

By Jon Speer on September 6, 2020

Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...

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...

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