DS/EN ISO 14155:2020/A11:2024
Current
The latest, up-to-date edition.
Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)
14-01-2025
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
| Committee |
DS/S-258
|
| DocumentType |
Amendment
|
| PublisherName |
Danish Standards
|
| Status |
Current
|
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