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Mdr Documentation Submissions
Found 1 free book(s)Technical Documentation and Medical Device Regulation
www.medical-device-regulation.euthe technical documentation should be developed and handled. As mentioned in the first paragraph from Annex II of the MDR, ‘the technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the