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Medical Device Documentation

This course covers all the required documentation specified by the Medical Device Regulation (2017/745 & IVDR 2017/746) Annex II and the FDA 21CFR 820.30 Design Control process. The course goes through all the key documents and explains the authorities’ expectations regarding the content and the maturity of the documents. Based on a Stage-gate development process, the course also specifies the order of the different documents and explains why it is important to prepare some documents before others.

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Do you want to know more about Finished Products Engineering?
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Do you want to know more about Finished Products Engineering?
Do you want to know more Process Engineers?
Do you want to know more Medical Device & QA?
Do you want to know more about Finished Products Engineering?
Do you want to know more Process Engineers?
Do you want to know more Medical Device & QA?