ThrombUS+ D2.2: Regulatory framework, security, safety and ethics strategy and guidelines.

A report detailing the compliance requirements for the development of ThrombUS+ outcome according to the corresponding EU legal frameworks, including security, safety, privacy, and ethical considerations.This report is the output of Task 2.2. The aim of Task 2.2 is to identify and early address the compliance requirement for the development of medical devices according to the corresponding EU legal framework, namely Medical Device Regulation (MDR) (EU 2017/745), along with the identification and inclusion of further relevant standards and guidelines according to the nature of the ThrombUS+.