According to the MDR Regulation, the technical documentation must be complete, well-structured, and contain sufficient information to demonstrate that the…

Biological evaluation is a crucial aspect of medical device development. It should first be addressed during the design verification phase…

The Procedure Pack File for medical device systems and procedure packs, as well as the Technical Documentation for IVD kits,…

The Medical Devices Regulation (EU) 2017/745 (MDR), which came into effect in 2017 to replace the directives (93/42/EEC on medical…

All medical devices, regardless of their classification, require a clinical evaluation to demonstrate the acceptability of the risks associated with…

The first step in preparing the TD is to create a Technical Documentation template that allows for the inclusion of…

For all medical devices except custom-made devices, manufacturers are required to draft and maintain up-to-date Technical Documentation in accordance with…

The introduction of reporting requirements for post-market surveillance (PMS) by the MDR necessitates a more coherent, standardized, and systematic review…