Swiss Medtech – MDR compliance
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Swiss Medtech is organizing an new workshop on MDR compliance on 21 August 2019 in Vevey
The new edition of the MDR Workshop organized by Swiss Medtech will focus on medical devices, class Ir.
- Development, quality and regulatory managers
- Sterilization, decontamination and reuse of medical ancilliary
13h30 – 14h00 : Topic Introduction
- Armand Linge – Smith & Nephew : The necessity to name a “European Authorized Representative”
- Andrea Sparti – Cendres & Métaux : How to distinguish the MD classes Ir and IIa?
- Daniel Delfosse – Mathys SA Bettlach : Practical examples of documentation technique and DM classe Ir sampling
14h00 – 15h30 : Interactive session on specific topics
- Ir classification definition (distinction with Ia class)
- Sampling with NB possibility (or necessity)?
- Which documentation technique is required / examined by NB?
- How to document aspects linked to the reuse of a device, in particular cleansing, disinfection, sterilization, maintenance and functional test?
- Efficient documentation technique reporting
15h30 – 17h00 : Discussion and pooling results
- Results documentation
- Sharing of results with participants
PROGRAMME AND REGISTRATION
The event’s official language is French.