MDRC convened Kenya Bureau of Standards, Pharmacy and Poisons Board, African Regional Standards Organization, US Food and Drug Administration, International Electrotechnical Commission and Medak to discuss on opportunities to streamline Conformity Assessment and Import process of Medical Devices.
Agenda
Recording
Presentations
Conformity Assessment IECEE CB Scheme. The Whats and the Hows – Steven Margis – IECEE
Conformity Assessment Process for Medical Devices in Kenya – Leinad Mwendwa – KEBS
International Standards. The Role of National – Regional Standards Development Organizations – Essential Standards for Medical Devices and IVDs – Sandra Umugwaneza – ARS
International Standards The Role of National Regional Standards Development Organizations Essential Standards for Medical Devices and IVDs – Terry Woods, Scott Colburn – USFDA-CDRH
