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

Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

By Nick Tippmann on March 16, 2021

The IVD market reaches into all corners of the world, and for many device companies, this niche prod...

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 ...

Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events

By Nick Tippmann on October 19, 2020

New capability automates the quality event process through customized templates that increase effici...

How to Write a Nonconformance Report

By Barret Mueller on October 4, 2020

Nonconformance is a word no quality manager wants to hear.

FDA Form 483 Observations and Warning Letters - What’s the Difference?

By Jon Speer on February 21, 2020

If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...

FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid

By Jon Speer on November 27, 2019

If you’re a medical device company selling or planning to sell into the US market, you should be fam...

4 Tips for Handling Nonconformances

By Jon Speer on February 12, 2018

The safety and efficacy of your product rides heavily on the quality of the components that make it ...

Standard Conformity or Regulatory Compliance? Distinguishing the Two

By Jon Speer on October 9, 2017

So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...

What Does a Risk-Based QMS Mean?

By Jon Speer on October 1, 2017

What exactly is a risk-based QMS?

What Should Really Trigger a CAPA?

By Jon Speer on April 4, 2017

Over years of working with medical device companies, we’ve found that there is a particular area tha...

4 Key Compliance Issues for Medical Device Companies

By Jon Speer on February 11, 2017

The goal for most creators of new medical devices is to be able to get them to market as quickly as ...

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