Introduction to the clinical evaluation of medical devices and corresponding regulatory requirement to obtain and maintain the CE marking
Post-marketing surveillance process and phases
Summary of the XP S99-223 standard on the management of the benefit/risk ratio of medical devices for regulatory purposes
Roles and obligations of the Medical Device actors (manufacturer, authorised representative, importer and distributor) in Europe
Principles and techniques to perform a regulatory watch, focus on the steps of the process and the means of automation
Quality manual template for medical device manufacturers, according to ISO 13485 and 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 of Medical Device (MD) in the context of the Regulation (EU) 2017/745.
Overview of the XP S99-223 standard