2020.02.23 EUにおける医療機器規制(MDR/IVDR) Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a 'person responsible for regulatory compliance'(PRRC)
2019.02.18 FDA 510(k) The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]