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Showing posts tagged with: FDA 510k

Validating or Not Validating for Intended Use?

Validating or Not Validating for Intended Use?

When I say Validation For Intended Use, most of you picture an extensive documentation required by ISO and FDA. Although Validation for intended use documentation is useful for several reasons (ensure accuracy, reliability, consistent intended performance, the ability to discern invalid or altered records, etc.) people mainly think of it as a regulatory requirement only. In FDA's...
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Weekly Cup of Joe #26 – Advantages of An Integrated PM and QMS

Weekly Cup of Joe #26 – Advantages of An Integrated PM and QMS

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance. Bolt-on Quality Management Apps, put the cart before the horse The mistake...
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What if staying ISO and FDA compliant was easy?

What if staying ISO and FDA compliant was easy?

In the previous article, I took a closer look at ISO13485:2016 and the pending doomsday scenario. In this article, I’ll take a closer look at the similarities between ISO 13485:2016 and FDA QSRs. Similarities between ISO 13485:2016 and FDA QSR A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more and sounds...
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Are companies ready for the ISO 13485:2016? “a closer look”

Are companies ready for the ISO 13485:2016? “a closer look”

Surprisingly this is a real and topical question. At every MedDev or MedTec oriented exhibition this is the off-stage topic, actually more like main grippe session. The 2016 version requires a lot more emphasis on risk management and embedding risk management into the quality system processes. But really there are two issues in play with respect...
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