Join experts from regulatory agencies and the medical device industry as we share perspectives on current IMDRF initiatives related to the RPS ToC Pilot and International Standards applications and conformity assessment.

Agendas under Related Documents.

DITTA-GMTA: RPS TOC Workshop

DATE: Monday, 18 September 2017
TIME: 08:30-12:00
LOCATION: Lord Elgin Hotel, 100 Elgin Street, Ottawa, ON K1P 5K8
Objective:   Share experiences, benefits, and challenges with IMDRF RPS ToC Pilot; discuss next steps and plans for future implementation.  Workshop sessions will explore perspectives of all stakeholders, including regulators/reviewers and industry members who took part in the Pilot.  The workshop will also include discussion about next steps and an opportunity to exchange ideas with regulators about the future of electronic regulatory submissions.

DITTA WORKSHOP: The benefits of international standards for regulatory conformity

DATE: Monday, 18 September 2017
TIME: 12:00 – 16:00
LOCATION: Lord Elgin Hotel, 100 Elgin Street, Ottawa, ON K1P 5K8
Objective:   Workshop will focus on the application of standards in the actual conformity assessment process from the viewpoint of the different stakeholders. Participants will learn about the formal use and application of standards in this process. In a second panel round we will engage on the elements for drafting excellent standards which satisfy all stakeholder needs.

Register here.