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Showing posts tagged with: medical manufacturers

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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ISO 13485 – 2016 Checklist

ISO 13485 – 2016 Checklist

A checklist on where to start, and what to do first   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, you’re reading this because your strategy requires QMS oversight and your first question is likely “where to start” and “what...
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ISO 13485:2016 - New terms to take note of

ISO 13485:2016 - New terms to take note of

Differences and similarities between the ISO 13485:2003 and ISO 13485:2016 editions. ISO 13485:2003 only had a few defined terms with clear definitions. However, in the new edition of ISO 13485:2016 sixteen new terms are added with longer definitions. Let's see what are the differences and similarities between the editions. Terms that remained the same Advisory notice - giving...
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ISO 13485:2016 – Creating a Glass Ceiling for Startups

ISO 13485:2016 – Creating a Glass Ceiling for Startups

May 2016 was a dark day for medical small companies and startups, it was the day the ISO created a glass ceiling for Medical Startups. A glass ceiling! Yes, because ISO13485:2016 essentially puts a glass ceiling on medical start-ups with a daunting new array certification requirements that will disproportionally impact startups and small companies. Essentially, to properly...
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