Free Sale Certificate according to EU MDR
The free sale certificate is an essential document to expert medical devices. These are certificates that are aiming at facilitating…
Product Life Cycle for Medical Devices
The understanding and implementation of the regulatory requirements in the early stages of the product life cycle will ensure and…
Harmonised Standards and EU MDR 2017/745
Harmonised standards (HS) play a pivotal role in the European Union’s regulatory framework for medical devices, particularly under Regulation (EU)…
Substantial Changes for Design and Quality System: an Overview
The definition of substantial changes has always been very critical for medical device manufacturers. We have already been talking about…
EU Declaration of Conformity
The Declaration of Conformity is one of the key document asked to be prepared by medical device manufacturer in order…