I'm part of a team in the process of generating a STED covering the Technical Documentation (for a longstanding Class IIb device) in accordance with Annnex II of the MDR.
Within section 6 of Annex II, 'Product Verification and Validation', the final subsection of 6.1b) is titled 'Performance and Safety'.
Having already completed the preceding sections of 6.1, covering preclinical and bench testing, biocompatibility/chemical/micro characterisation, electrical safety etc, I think 'Performance and Safety' is very well covered already.
Do you have any advice as to what is expected under the 'Performance and Safety' subsection?
Many thanks
Within section 6 of Annex II, 'Product Verification and Validation', the final subsection of 6.1b) is titled 'Performance and Safety'.
Having already completed the preceding sections of 6.1, covering preclinical and bench testing, biocompatibility/chemical/micro characterisation, electrical safety etc, I think 'Performance and Safety' is very well covered already.
Do you have any advice as to what is expected under the 'Performance and Safety' subsection?
Many thanks