GHTF · International guidance
GHTF/SG1/N78:2012
Principles of Conformity Assessment for 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/N78:2012
- Published (source metadata)
- November 2012
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About this guidance
Principles of Conformity Assessment for Medical Devices
Foundational guidance on conformity assessment methodology for medical device regulation. Establishes principles for demonstrating product compliance with regulatory requirements.