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

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

By Taylor Brown on November 23, 2020

Developing Pediatric Medical Devices: An Innovative Approach

By Erica Loring on November 10, 2020

The design and development of pediatric medical devices continue to be a challenging field.

Medical Device Biocompatibility 101

By Erica Loring on November 8, 2020

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

Everything You Need to Know about Human Factors Engineering for Your Medical Device

By Tom Rish on November 1, 2020

Human factors are a key part of medical device development and the sooner they’re addressed in the d...

How to Write a Nonconformance Report

By Barret Mueller on October 4, 2020

Nonconformance is a word no quality manager wants to hear.

What is a Multiple Function Device?

By Nick Tippmann on September 30, 2020

What is a multiple function device? From a high level, it’s a product with at least one portion that...

Challenges related to Home Use Devices

By Nick Tippmann on September 10, 2020

What could go wrong as more medical device products are used at home and in similar non-traditional ...

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

By Nick Tippmann on September 2, 2020

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Specia...

How Jon Speer Met His Most Frequent Guest: Mike Drues

By Nick Tippmann on August 26, 2020

Reminiscing about past and present lessons learned from listening to conversations with this show’s ...

Document Control for Medical Device Companies: The Ultimate Guide

By Jon Speer on August 23, 2020

According to the original data findings of our 2020 State of Medical Device Product Development and ...

Unannounced Audits: A Survival Guide for Quality Managers

By Jon Speer on August 16, 2020

We’re in an industry that requires preparation. Unlike less regulated industries, there’s an expecta...

5 Tips for Medical Device Registration across Global Markets

By Jon Speer on August 9, 2020

You have compiled all of the necessary documentation for your regulatory submission, submitted it to...

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