Webinar on Conformity Assessment for Medical Devices – Personalized Medical Devices

The Medical Device Regulatory Convergence Project (MDRC) held the Webinar on Conformity Assessment for Medical Devices – Personalized Medical Devices on 6 and 7 February.

The Webinar had approximately 20 officials attend the two-day session, which focused on conformity assessment and personalized medical devices; the latter topic was included at MOH’s request. The MDRC team also introduced the conformity assessment checklist and offered to work with officials on tailoring it to their needs. Speakers included representatives from MDRC, NIST, USFDA, TIC Council, TGA Australia, and HAS Singapore.

Agenda

Recordings

Day 1

Day 2

Presentations

Day 1

Conformity Assessment – Ensuring Compliance with International Obligations: Checklist

Marina Carvalho – MDRC

Conformity Assessment – The How to: Regulator and CABs

The Accreditation Scheme for Conformity Assessment (ASCA) Program: Putting Standards to Work in Conformity Assessment – Scott Colburn – US FDA

Day 2

Personalized Medical Devices – International References and Regulators’ Experience

Personalized Medical Devices – Regulatory Pathways (IMDRF/PMD WG/N58) – Suhuling Peng – HAS Singapore