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Published July 17, 2024 | Version 1
Project deliverable Open

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

Authors/Creators

  • 1. VDE Association for Electrical Electronic & Information Technologies
  • 2. ROR icon Athena Research and Innovation Center In Information Communication & Knowledge Technologies

Description

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+.

Files

ThrombUS_D2.2_v1.0.pdf

Files (1.5 MB)

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Additional details

Funding

European Commission
ThrombUS - ThrombUS+: Wearable Continuous Point-of-Care Monitoring, Risk Estimation and Prevention for Deep Vein Thrombosis 101137227