Summary of PMCF requirements: Post-Market Clinical Follow-up of medical devices, according to Regulation 2017/745 (definition, methods, expected documents…)
Guidance on the implementation of Regulation (EU) 2017/745 on medical devices, particularly for manufacturers.
Presentation of the Periodic Safety Update Report for medical devices (PSUR) required by the Medical Device Regulation (UE) 2017/745
This article gives the state of the art in Cybersecurity of Medical Devices, to provide a overall view of a cybersecurity management process.
IEC 62304 Medical device – Software life cycle defines the life cycle requirements for medical device software, the set of processes, activities, and tasks described in this standard.
Summary of the standard IEC 62366-1 Medical devices Usability engineering: examples and methods.
Comparison of “Notified Body” fees in the context of the european regulation on medical devices
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