GHTF · International guidance
GHTF/SG1/N044:2008
Role of Standards in the Assessment of Medical Devices
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/SG1/N044:2008
- Published (source metadata)
- March 2008
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About this guidance
Role of Standards in the Assessment of Medical Devices
Guidance on the use of international standards in medical device evaluation. Addresses standards recognition and application in regulatory assessment.