risk management files compliant with ISO 14971.software requirements specifications, software architectures) compliant with FDA and IEC 62304 requirements Pass CE-approvals and FDA submissions quickly and safely with the Johner Institute's help to compile Technical Files / submission documents including establish a quality management system compliant with ISO 13485 respectively 21 CFR part 820.ĬE Mark = Technical File + Quality Management System CE-mark and FDA approval: How the Johner Institute helps.compile a technical file proving the compliance of your product with FDA and European regulations and standards such as IEC 62304, ISO 14971, IEC 62366 and IEC 60601-1.Preconditions: If you want to market your medical device in Europe or in the US you have to
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