ISO EN 13485:2016 - Introduction to the Requirements of the Medical Devices Quality Management System (MDQMS) - BQC Πιστοποίηση Συστημάτων Διαχείρισης ISO 9001,ISO 22000, ISO 14001,ISO 18001

ISO EN 13485:2016 – Introduction to the Requirements of the Medical Devices Quality Management System (MDQMS)

EN ISO 13485:2016 A11:2021 (recent publication by CEN and CENELEC with new annexes ZA and ZB linking the standard to the MDR and IVDR requirements)
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, (application date: 26 May 2021)
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices (application date: 26 May 2022)
Substitution (in force as applicable in cases of product categories in transition period and other relevant references):
Directive 93/42/EEC on Medical Devices products: Harmonization of National Legislation: DY8d/G.P.oik130648/Government Gazette 2198B/02-10-2009
Directive 90/385/EEC on Active Implantable Medical Devices: Harmonization of
National Legislation: DY8d/G.P.oik130644/Government Gazette 2197B/02-10-2009
Directive 98/79/EC – 27/10/98 (FOR IN VITRO DIAGNOSTIC MEDICAL PRODUCTS): Harmonization: DY8d/oik3607/892/Government Gazette 1060B’/10-8-01

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