Search

Request for expressions of Interest to participate in the IMDRF TOC pilot plan, Regulated Product Submission Working Group, Coordinator Patrick Axtell - US Food and Drug Administration (FDA), Closed Friday, 21 August 2015.

Regulated Product Submission - Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions, Regulated Product Submission Working Group, Coordinator Nancy Shadeed, Closed 1 June 2015.

In-Vitro Diagnostics Market Authorization Table of Contents, Regulated Product Submission Working Group, Coordinator Patrick Axtell - US Food and Drug Administration (FDA), Closed Friday, 17 January 2014.

Regulated product submission (RPS) Table of contents, Regulated Product Submission Working Group, Coordinator Patrick Axtell - US Food and Drug Administration (FDA), Closed Friday, 21 June 2013.

Software as a Medical Device (SaMD): Clinical Evaluation, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel, Closed 13 December 2016.

Software as a Medical Device (SaMD): online survey now open, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel - US Food and Drug Administration (FDA), Closed Monday, 3 August 2015.

Software as a Medical Device (SaMD): Application of Quality Management System, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel, Closed 01 June 2015.

Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel - US Food and Drug Administration (FDA), Closed Saturday, 31 May 2014.

Standalone Software: Key Definitions, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel - US Food and Drug Administration (FDA), Closed Friday, 30 August 2013.

Optimizing Standards for Regulatory Use, IMDRF recognized standards Working Group, Coordinator Matthias Neumann, Closing date 24 May 2018.