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15 Reasons Why Medical Device Companies Choose Greenlight Guru - Featured Image

15 Reasons Why Medical Device Companies Choose Greenlight Guru

The medical device industry has been undergoing a major shift for the past 20 years, and now that sh...
Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016 - Featured Image

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

One thing that seems to be constant in the global medical device industry is change.
Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017 - Featured Image

Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017

Thanks for helping make 2017 another big and exciting year for Greenlight Guru filled with tremendou...
Top 30+ Medical Device Conferences You Should Be Attending in 2018 - Featured Image

Top 30+ Medical Device Conferences You Should Be Attending in 2018

If you’re looking to land your company's next big deal, keep up on the latest regulatory trends, for...
How to Streamline the Customer Complaint Handling Process - Featured Image

How to Streamline the Customer Complaint Handling Process

It can be quite nerve-wracking the very first time your medical device company receives a complaint ...
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices - Featured Image

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

What Is This CAPA Guide About? As an experienced medical device professional who has worked with doz...
What is a “Quality Data Source” for your CAPA Process? - Featured Image

What is a “Quality Data Source” for your CAPA Process?

There’s a phrase that the FDA states in their policies around CAPA, which elicits a few questions. T...
What Devicemakers Need to Know About Medical Device Reporting (MDR) - Featured Image

What Devicemakers Need to Know About Medical Device Reporting (MDR)

Medical device reporting, or MDR: what is it? What isn’t it? Why is it important?
5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare) - Featured Image

5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)

What should the medical device industry expect in 2017? Great question. I’d like to share some of my...
Top 10 Most Popular Medical Device Articles of 2016 from greenlight guru (Plus Top 5 Free Webinars and Podcasts) - Featured Image

Top 10 Most Popular Medical Device Articles of 2016 from greenlight guru (Plus Top 5 Free Webinars and Podcasts)

Thanks for helping make 2016 another big and exciting year for Greenlight Guru filled with growth! W...
ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820 - Featured Image

ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820

The publication and release of ISO 13485:2016 earlier this year is a significant movement for the me...
Tips & Pointers for Effective Internal Quality Audits with Kyle Rose - Featured Image

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Internal audits might be inconvenient and a bit nerve-wracking, but they’re also educational.

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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