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