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

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

Developing Pediatric Medical Devices: An Innovative Approach - Featured Image

Developing Pediatric Medical Devices: An Innovative Approach

The design and development of pediatric medical devices continue to be a challenging field.
Medical Device Biocompatibility 101 - Featured Image

Medical Device Biocompatibility 101

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 - Featured Image

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

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 - Featured Image

How to Write a Nonconformance Report

Nonconformance is a word no quality manager wants to hear.
What is a Multiple Function Device? - Featured Image

What is a Multiple Function Device?

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 - Featured Image

Challenges related to Home Use Devices

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 - Featured Image

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

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 - Featured Image

How Jon Speer Met His Most Frequent Guest: Mike Drues

Reminiscing about past and present lessons learned from listening to conversations with this show’s ...
Document Control for Medical Device Companies: The Ultimate Guide - Featured Image

Document Control for Medical Device Companies: The Ultimate Guide

According to the original data findings of our 2020 State of Medical Device Product Development and ...
Unannounced Audits: A Survival Guide for Quality Managers - Featured Image

Unannounced Audits: A Survival Guide for Quality Managers

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 - Featured Image

5 Tips for Medical Device Registration across Global Markets

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

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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