Regulation (EU) 2017/745

Surveillance apres commercialisation - Dispositifs Medicaux

Post-marketing surveillance (PMS) for medical devices

By Guillaume Promé
Sep. 30, 2021 Regulation (EU) 2017/745

Post-marketing surveillance process and phases

XP S 99-223

[summary] XP S99-223 – Medical Devices – Benefit/risk management

By Guillaume Promé
Sep. 29, 2021 Regulation (EU) 2017/745, Risk management

Summary of the XP S99-223 standard on the management of the benefit/risk ratio of medical devices for regulatory purposes

Roles of the organizations as defined in the Medical Devices Regulation

Roles and obligations in the Medical Devices Regulation

By Guillaume Promé
Sep. 28, 2021 Regulation (EU) 2017/745

Roles and obligations of the Medical Device actors (manufacturer, authorised representative, importer and distributor) in Europe

regulatory watch for medical devices

Doing a Regulatory Watch for medical devices

By Guillaume Promé
Sep. 27, 2021 Regulation (EU) 2017/745

Principles and techniques to perform a regulatory watch, focus on the steps of the process and the means of automation

Quality manual for medical device manufacturer

Quality manual, ISO 13485 and MDR, free template

By Guillaume Promé
Sep. 24, 2021 ISO 13485, Regulation (EU) 2017/745

Quality manual template for medical device manufacturers, according to ISO 13485 and Regulation (EU) 2017/745

ISO 13485:2016+A11:2021

EN ISO 13485/A11: Annex ZA and ZB for regulations 2017/745 and 2017/746

By Guillaume Promé
Sep. 23, 2021 ISO 13485, Regulation (EU) 2017/745

Review of Amendment A11 to EN ISO 13485:2016, containing Annexes ZA and ZB for regulations 2017/745 and 2017/746.

definition medical device

Definition of a Medical Device in Europe

By Guillaume Promé
Sep. 22, 2021 Regulation (EU) 2017/745

Definition of Medical Device (MD) in the context of the Regulation (EU) 2017/745.