Understanding the evolving requirements during the transition from proof-of-concept to medical device software validation in the EU projects

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Understanding the evolving requirements during the transition from proof-of-concept to medical device software validation in the EU projects

Description

The data (Appendix 1–4, the participant information documents and the Informed consents document) used in the article: Polishchuk & Aholaakko 2024 Understanding the evolving requirements during the transition from proof-of-concept to medical device software in the EU projects. The study was carried out for the EU SHAPES Horizon 2020 project Grant Number 857159.
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Year of publication

2024

Authors

Laurea University of Applied Sciences

Aholaakko, Teija-Kaisa Orcid -palvelun logo - Creator

Polishchuk, Anna Orcid -palvelun logo - Creator, Publisher

Other information

Fields of science

Medical engineering

Language

English

Open access

Open

License

Creative Commons Attribution 4.0 International (CC BY 4.0)

Keywords

evaluation, software, regulations, clinical evaluation, EU SHAPES project, medical device

Subject headings

qualitative research, decrees, software development