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

What are the Top Compliance Issues Plaguing Medical Device Manufacturers?

By Nick Tippmann on November 10, 2021

Medical device companies must comply with a list of strict requirements throughout the duration of t...

Top 3 Reasons for FDA 483 Observations in 2020

By Etienne Nichols on September 12, 2021

The US Food and Drug Administration (FDA) has released the quality system inspection data for citati...

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

By Nick Tippmann on June 14, 2021

What did FDA report as the most-cited issues during medical device inspections for the fiscal year o...

Preparing for Remote and On-Site Inspections and Audits

By Nick Tippmann on February 24, 2021

How can medical device companies be better prepared for remote and on-site inspections and audits? P...

Virtual Auditing in a Post-COVID World of Digital Compliance

By Nick Tippmann on February 17, 2021

What do auditing and compliance protocols look like during a pandemic? Medical device companies cont...

5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes

By Taylor Brown on February 14, 2021

Your internal quality audits should be much more than a “checkbox” requirement on your compliance to...

The Ultimate Internal Audit Checklist Every Medical Device Company Needs

By Erica Loring on October 25, 2020

It was nothing more than a checklist that saved $175 million and 1,500 lives.

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...

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...

13 Tips For Audit Etiquette Every Medical Device Company Should Know

By Taylor Brown on August 11, 2019

I love audits. Seriously! It is a hybrid experience, like a kindergarten show-and-tell with a classi...

FDA QSIT: Preparing Your Medical Device Company for an Inspection

By Jon Speer on June 17, 2019

Preparing for an FDA QSIT inspection can be a daunting task for medical device manufacturers. Many c...

What to Expect During an FDA QSIT Inspection

By Jon Speer on February 17, 2019

You arrive at work one morning and there are FDA inspectors sitting in your waiting area. If you are...

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