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Reflections and stories from life in the medical device industry.

The secret requirements list

You perhaps believe that you can read which requirements apply in the laws and standards for medical device manufacturers like ISO 13485 or 93/42/EEC, and to an extent that’s true. But to an increasing extent I’m encountering requirements that notified bodies and authorities have set and which aren’t documented anywhere. These requirements are much more […]

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News for ISO 10993-1:Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process.

ISO 10993:2009 Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process has a secondary objective of avoiding redundant in-vivo tests. But even if that is true for Europe, important markets such as US and China still require that all the tests are done, so the question is whether the possibility […]

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Risk management conference

The risk management conference participants discussed FMEA in relation to ISO 14971 and risk analysis. The conclusion was that FMEA is not risk management, nor risk analysis. Not so revolutionising, but still creates discussions. On the two-day risk management conference in Berlin, representatives from industry and notified bodies met to discuss risk management. Presentations were […]

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Impressions from Medtech Investment Day

On Wednesday, I was booked for two practice sessions for my pitch. The idea is that you should present the company in 4 minutes. Four minutes is an incredibly short time! Apparently I did something right, because on Thursday Vivoline Medical AB won the contest MedTech Investment Day Award. But it was of course not […]

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