GHTF · International guidance
GHTF/SG5/N7:2012
Scientific Validity Determination and Performance Evaluation
International Medical Device Regulators ForumGHTF/IMDRFTechnical guidance
International guidance
This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.
Source identity
- Issuing body
- GHTF/IMDRF
- Reference
- GHTF/SG5/N7:2012
- Published (source metadata)
- November 2, 2012
Readable full text
Open a language version
Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
About this guidance
Scientific Validity Determination and Performance Evaluation
Guidance on establishing scientific validity and conducting performance evaluation for IVD devices. Covers analytical and clinical performance assessment.