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What Does a Risk-Based QMS Mean? - Featured Image

What Does a Risk-Based QMS Mean?

What exactly is a risk-based QMS?
How to Switch to eQMS Software When You're Just Using Paper - Featured Image

How to Switch to eQMS Software When You're Just Using Paper

How reliable is your paper-based quality management system? This situation plays out in medical devi...
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...
What Medtech Startups Should Know About Quality Systems To Not Go Overboard - Featured Image

What Medtech Startups Should Know About Quality Systems To Not Go Overboard

MedTech startups thrive on lean-ness. Part of lean-ness is knowing how and when to scale regulatory ...
4 Medical Device Quality System Musts for Startups - Featured Image

4 Medical Device Quality System Musts for Startups

Medical device startups have a pile of things to address yet often don’t have the pile of money to t...
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...
5 Reasons Why You Need To Implement a QMS or Bust - Featured Image

5 Reasons Why You Need To Implement a QMS or Bust

Look, I get it. Worrying about implementing a quality management system isn't on your list of the to...

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