Greenlight Guru Medical Device Blog

GET THE LATEST UPDATES FROM OUR BLOG:

Join 68,000+ other medical device professionals outperforming their peers.

13 Tips For Audit Etiquette Every Medical Device Company Should Know - Featured Image

13 Tips For Audit Etiquette Every Medical Device Company Should Know

I love audits. Seriously! It is a hybrid experience, like a kindergarten show-and-tell with a classi...
FDA Warning Letters and Form 483 Observations - What’s the Difference? - Featured Image

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

If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...
Quality Management Audit or Assessment? - Featured Image

Quality Management Audit or Assessment?

What's the difference between the two? Plenty!
How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips) - Featured Image

How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips)

As your company heads back from holiday breaks, what’s happening into the New Year?
How to Prepare for the Medical Device Single Audit Program (MDSAP) - Featured Image

How to Prepare for the Medical Device Single Audit Program (MDSAP)

How is your understanding of the Medical Device Single Audit Program (MDSAP)?
Standard Conformity or Regulatory Compliance? Distinguishing the Two - Featured Image

Standard Conformity or Regulatory Compliance? Distinguishing the Two

So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...
FDA Inspections and ISO Audits: What is the Difference? - Featured Image

FDA Inspections and ISO Audits: What is the Difference?

It’s every medical device manufacturer's favorite time…the arrival of an FDA inspector or ISO audito...
What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

Over years of working with medical device companies, we’ve found that there is a particular area tha...
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.
4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer - Featured Image

4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer

As an engineer, there’s not a lot that makes me nervous. Going through an FDA / ISO audit? That make...

The Greenlight Guru Medical Device Blog

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

Our Most Popular Posts

Topics

See More Topics...