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ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements - Featured Image

ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements

Medical device companies, listen up. There is zero excuse for not complying with medical device qual...
Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson - Featured Image

Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

On today's episode of the Global Medical Device Podcast, we’re discussing how startup entrepreneurs ...
A Step-by-Step Guide to Determine How Your Medical Device Will Be Classified - Featured Image

A Step-by-Step Guide to Determine How Your Medical Device Will Be Classified

What I am about to share with you is a guide to medical device regulatory classification. In this gu...
How To Prepare for an FDA Inspection (Plus 5 Tips) - Featured Image

How To Prepare for an FDA Inspection (Plus 5 Tips)

Over the past several years, FDA has been more aggressive and active in performing medical device co...
How To Flush $400,000 Down the Drain Fighting the FDA - Featured Image

How To Flush $400,000 Down the Drain Fighting the FDA

How much does it cost to address FDA 483 observation and warning letter issues? Unless you have been...
The Ultimate Guide To Design Controls For Medical Device Startups - Featured Image

The Ultimate Guide To Design Controls For Medical Device Startups

An FDA Inspection Will Happen - Featured Image

An FDA Inspection Will Happen

If you are a medical device company in the U.S., did you know FDA is required to inspect all class I...

The greenlight.guru Medical Device Blog

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