Medical Innovations Incubator GmbH’s Post

The #NotifiedBody plays a central role in the process of becoming a medical device manufacturer. We spoke to Dietmar Schaffarczyk, auditor at QS Schaffhausen AG, to find out more about what the NB expects from young #MedTech startups.   Our key takeaways: ◾ NBs must maintain their independence in their assessments, which is why they must not offer direct advice. ◾ While each company must be compliant, NBs take into account the current status of a company. ◾ Long-term success can only be guaranteed by building internal expertise in addition to external support. ◾ When you first contact an NB for a QMS audit, for example, 65% of the documentation should be ready. Read the full interview here 👉 https://lnkd.in/gTvz9a5e

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