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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...
20 Most Popular Medical Device Posts of 2015 from greenlight.guru - Featured Image

20 Most Popular Medical Device Posts of 2015 from greenlight.guru

2015 was a huge year for greenlight.guru! A lot happened. From publically launching our product in F...
Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It) - Featured Image

Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)

Getting FDA 510(k) market clearance is a significant, meaningful milestone and achievement for any m...
5 Reasons Why You Need To Implement a QMS Now or Bust! - Featured Image

5 Reasons Why You Need To Implement a QMS Now or Bust!

Look, I get it. Worrying about implementing a quality management system isn't on your list of the to...
The Ultimate Guide To Design Controls For Medical Device Startups - Featured Image

The Ultimate Guide To Design Controls For Medical Device Startups

The greenlight.guru Medical Device Blog

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