Work

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

Year: 2024

Type: article

Abstract: 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+.

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.12726792

Authors: Prinz, Thorsten, Narten, Zoe, Wenner, Hans, Didaskalou, Stylianos, Schlötelburg, Cord

Institution: Athena Research and Innovation Center In Information Communication & Knowledge Technologies

Language: English

Topic: Healthcare Regulation

Subfield: Health Information Management

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

Funder: European Commission