The International Medical Device Regulators Forum has an open consultation on a proposal to update guidances clinical evaluation documents that were originally generated by the GHTF:
http://www.imdrf.org/consultations/cons-clinical-evaluation.aspThe documents address both clinical investigations and clinical evaluations.
Comments on the proposed updates are due June 5.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------