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Guidances
GHTF/SG1/N044:2008 Role of Standards in the Assessment of Medical Devices
AHWP/WG2-WG8/F002:2014 Role of Standards in the Assessment of Medical Devices
GHTF/SG1/N77 Principles of Medical Devices Classification
GHTF/SG1/N78 Principles of Conformity Assessment for Medical Devices
IMDRF/GRRP WG/N47 Essential Principles of Safety and Performance of Medical Devices and IVD
IMDRF/Standards WG/N51 FINAL:2018 Optimizing Standard for Regulatory Use
IMDRF Standards Working Group Reports
List of international standards recognized by IMDRF management committee members.
Improving the quality of international standards for regulatory use.
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