Regulatory Watch
Regulatory watch consists in the activity related to keep under active monitoring all the standards and regulation applicable to your medical devices and to your quality management system, in order
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