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Software as a Medical Device (SaMD): Clinical Evaluation

A Proposed Document has been released by the International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD) Working Group.

This consultation will close on Tuesday 13 December 2016.

Working Group Chair: Bakul Patel

Thank you for your contribution aiming at the validation of the IMDRF document.

Consultations

Please use the comments template to provide comments on the Proposed Document and email comments to Bakul.Patel@tda.hhs.gov.