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Greenlight Guru Medical Device Blog

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What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers...
ISO 11137: An Introduction to Gamma Sterilization Validation - Featured Image

ISO 11137: An Introduction to Gamma Sterilization Validation

For many medical device companies, sterilization is one of the final hurdles they have to clear befo...
Tips for Virtual Audits Your Medical Device Company Can Implement Today - Featured Image

Tips for Virtual Audits Your Medical Device Company Can Implement Today

Auditing medical device manufacturers is one of the most important aspects of ensuring quality stand...
What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)? - Featured Image

What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)?

Quality management is an essential part of manufacturing any product, regardless of size, complexity...
What is an ISO Audit? - Featured Image

What is an ISO Audit?

When it comes to medical devices, compliance isn’t based on the honor system.
For the Love of Internal Auditing - Featured Image

For the Love of Internal Auditing

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me...
Meet a Guru: Sara Adams - Featured Image

Meet a Guru: Sara Adams

One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical d...
Preparing for Remote and On-Site Inspections and Audits - Featured Image

Preparing for Remote and On-Site Inspections and Audits

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 - Featured Image

Virtual Auditing in a Post-COVID World of Digital Compliance

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 - Featured Image

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

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 - Featured Image

The Ultimate Internal Audit Checklist Every Medical Device Company Needs

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

The Greenlight Guru Medical Device Blog

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

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