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

Everything You Need to Know About Root Cause Analysis

By Brittney McIver on March 27, 2022

At some point, every medical device company will encounter an issue that requires an internal invest...

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...

Free Complaint Template for Medical Devices

By Jon Speer on October 21, 2020

One of the major post-market responsibilities of medical device companies is handling customer compl...

Free Template: Nonconformance Process for your Medical Device

By Jon Speer on October 20, 2020

Eventually, every quality professional is going to have to deal with nonconformance. In the medical ...

A Free CAPA Template for the Medical Device Industry

By Jon Speer on October 18, 2020

If you’re a medical device professional, you’ve likely heard the acronym “CAPA” before. For those wh...

How to Write a Nonconformance Report

By Barret Mueller on October 4, 2020

Nonconformance is a word no quality manager wants to hear.

3 Reasons Why Closed-Loop Traceability is a QMS Must

By Jon Speer on September 27, 2020

There is a growing expectation in the medical device industry of manufacturers to demonstrate closed...

CAPA Process - Step-by-Step Instructions [Infographic]

By Jon Speer on September 13, 2020

CAPA is an area that we talk about often, mainly because it’s still such a big issue for medical dev...

How to Perform Effective Root Cause Analysis

By Jon Speer on July 14, 2019

Picture this: something goes wrong with a medical device, and a complaint is issued. In a post-marke...

5 Most Common Problems with your CAPA Process

By Jon Speer on February 10, 2019

Year after year, the corrective and preventive action (CAPA) process continues to be the most widely...

How to Streamline the Customer Complaint Handling Process

By Jon Speer on November 27, 2017

It can be quite nerve-wracking the very first time your medical device company receives a complaint ...

Debunking 8 Commonly Held CAPA Myths

By Jon Speer on July 30, 2017

CAPA (Corrective and Preventive Action) is a source of ongoing issues within medical device companie...

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