IEC 62304:2006 – Medical Device Software
IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of software used as or within medical devices. It
Corrective and Preventive Actions (CAPA)
There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality Management System based on ISO 13485:2016. We have already been
The Role of Economic Operators within the EU MDR 2017/745
Who are Economic Operators according to EU MDR? The term Economic Operators is explained in article 2 of EU MDR and IVDR and it refers to manufacturers, authorised representative, distributors
Post-Market Surveillance for EU MDR
New Requirements for Post-market Surveillance The EU MDR 2017/745 and IVDR 2017/746 provides a big revolution for post-market surveillance, with a new framework of requirements which need to be implemented for
ISO 10993-1 : Biocompatibility Evaluation for Medical Devices
Biocompatibility evaluation according to ISO 10993-1 and the related biological risk assessment is one of the most important validation activities for medical device. It is an important process during the
