Combination Products and EU MDR 2017/745 Regulation
Combination products will undergo to a substantial change under the EU MDR 2017/745 and new regulatory challenges are at the…
Change Control Process
An efficient change control process is nowadays essential for any Quality Management System within a regulated environment and both FDA…
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…
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…
ISO 15223-1:2021 : New Symbols for Medical Devices
ISO 15223-1:2021 new symbols for medical devices In this paragraph, we will talk about the update of ISO 15223-1 that…
Cybersecurity Requirements for Medical Devices and EU MDR 2017/745
Introduction: Cybersecurity Requirements and EU MDR 2017/745 In the last decade, the role of cybersecurity substantially increased in the medical…