Workshop on ISO 13485 Certification
The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector collaborated with Health Canada to organize a workshop on Certification on ISO 13485 with the objective to learn on the experience from a regulator and an auditing organization on this process.
Agenda
Health Canada Approach to ISO 13485
Recording
Presentations
Health Canada Approach to ISO 13485 – Frédéric Hamelin – Health Canada – Canada
Auditing Approach to ISO 13485
Recording
Presentations
Approach of Auditing Organizations to ISO 13485 – Eamonn Hoxey – AAMI – USA
ISO 13485 Certification Process – Billi Jo Johnson – Dekra
REGULATORY COALITION PRINCIPAL MEMBERS