New Topic Group - Electronic Medical Device Submissions (EMDS)

We are pleased to announce the formation of a new Topic Group on Medical Devices and the move to electronic submissions.

The Electronic Medical Device Submissions group supports the ongoing work within the International Medical Device Regulator Forum (IMDRF) RPS Working Group (WG).

The topic group provides a neutral forum for ongoing discussions between vendors, industry and regulators on IMDRF RPS efforts and other electronic submission issues that may arise for medical devices. Key focus areas include:

  • Challenges that arise during piloting or implementation of the standard Table of Contents (IMDRF TOC);
  • Open dialog and assistance for key stakeholders to help them gain a better understanding of IMDRF RPS work,
  • Assisting the IMDRF RPS Working Group through communication and open discussion of challenges as they arise.

Topic Group Lead: Karin Sailor, Consultant & President of SRO, Inc.

Join us for the initial teleconference on Wednesday October 11, 2017 at 10:00am EDT / 14:00 GMT

  • If you are an IRISS member, sign up for the EMDS mailing list here
  • To join IRISS, click here