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How to Write a Nonconformance Report - Featured Image

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? - Featured Image

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 - Featured Image

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 - Featured Image

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 - Featured Image

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 - Featured Image

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 - Featured Image

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 - Featured Image

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...
What is FDA's Approach to Regulating AI/ML in Software as a Medical Device? - Featured Image

What is FDA's Approach to Regulating AI/ML in Software as a Medical Device?

By The RND Group on July 26, 2020
The FDA has released a discussion guideline and request for feedback regarding changes in the certif...
How to Build a QMS for a Medical Device - Featured Image

How to Build a QMS for a Medical Device

By Nick Tippmann on July 8, 2020
Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...
Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records - Featured Image

Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records

By Jon Speer on July 5, 2020
Some companies in the medical device industry show resistance to digital technology, preferring to u...
How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations - Featured Image

How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations

By Jon Speer on June 28, 2020
What is the expected process you should follow for your medical device design planning and controls?

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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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