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…
ISO 11135: Requirements for sterilisation with ethylene oxide
The ISO 11135 defines the requirements associated to the development, validation and routine control of the process of sterilization with…
Quality Agreement: An Overview
Quality agreement is one of the most important documentation in a context of medical device quality management system, including QMS…
Software Development Life Cycle
The software development life cycle is one of the key methodology used to manage software. In recent years, there has…
IEC 60601-1-11 : Requirements for Medical Equipment to be used at home
In recent years, the number of medical devices designed to be used within a home environment has increased substantially; this…
Quality Policy according to ISO 13485
The definition of the Quality Policy of the organization is one of the essential tasks associated to the top management…
ICH Q9 : Quality Risk Management
ICH is the International Council for Harmonisation and deals with the harmanonization of technical requirements for pharmaceuticals for human use;…
Investigator’s Brochure According to EU MDR 2017/745
The investigator Brochure is a well known document needed to have the authorization to perform a clinical investigation study on…
