The DHF, DMR, DHR, and the Technical Documentation File

This webinar will examine the existing requirements for the US  FDA's DHF -- including its derivative documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.  It will consider the EU's recently revised MDR and it's Technical Documentation File requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed.  Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences.