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

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

By Jon Speer on February 21, 2020
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...
FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid - Featured Image

FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid

By Jon Speer on November 27, 2019
If you’re a medical device company selling or planning to sell into the US market, you should be fam...
4 Tips for Handling Nonconformances - Featured Image

4 Tips for Handling Nonconformances

By Jon Speer on February 12, 2018
The safety and efficacy of your product rides heavily on the quality of the components that make it ...
Standard Conformity or Regulatory Compliance? Distinguishing the Two - Featured Image

Standard Conformity or Regulatory Compliance? Distinguishing the Two

By Jon Speer on October 9, 2017
So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...
What Does a Risk-Based QMS Mean? - Featured Image

What Does a Risk-Based QMS Mean?

By Jon Speer on October 1, 2017
What exactly is a risk-based QMS?
What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

By Jon Speer on April 4, 2017
Over years of working with medical device companies, we’ve found that there is a particular area tha...
4 Key Compliance Issues for Medical Device Companies - Featured Image

4 Key Compliance Issues for Medical Device Companies

By Jon Speer on February 11, 2017
The goal for most creators of new medical devices is to be able to get them to market as quickly as ...

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