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 the United States Food and Drug Administration (FDA) to organize on 29 August 2022, a webinar to provide an overview and practical implementation of IMDRF’s principles of conformity assessment for medical devices as well as a case study for software as a medical device.
Agenda
Recording
Presentations
Conformity assessment for medical devices overview and practical implementation
Principles of Conformity Assessment for Medical Devices (GHTF/SG1/N78:2012) – Erin Cutts – USFDA – USA
Practical Implementation of Conformity Assessment of Medical Devices
Practical Implementation of Conformity Assessment of Medical Devices: US FDA – Erin Cutts – USFDA – USA
Practical Implementation of Conformity Assessment of Medical Devices in Brazil – Francisco Iran Cartaxo – ANVISA – Brazil
Mukoil Romanos – INVIMA – Colombia
Practical application of Conformity Assessment of medical devices – Carolina Magnatti – ANMAT – Argentina
Overview of Conformity Assessment for DMs and Round Table on practical implementation. “Practical implementation of Conformity Assessment for software-oriented DM as DM” – Brenda Guadalupe Olvera – COFEPRIS – Mexico
Approach to Conformity Assessment for Medical Devices – The Industry Perspective
Approach to Conformity Assessment for Medical Devices – The Industry Perspective – “Fatemeh Razjouyan – Medtronic
