Transition process IVDD to IVDR - The practical implementation for In-Vitro Diagnostic Medical Devices in Switzerland
Are you working in Switzerland or for a Swiss company and need a concise overview of the new IVDR regulation and their practical implementation in Swiss law? Then you should attend this seminar!
- In-Vitro Diagnostic Regulation and In-Vitro Diagnostic Directive - the differences
- IvDO: translation of the new requirements into Swiss law
- Conformity assessment and CE marking
- Product design, technical documentation and performance evaluation of IVDs
- Market access and registration in Switzerland - comparison with EU regulations
- Post-Market Surveillance and vigilance
| Veranstaltungs-Code | FB24-522410-61077393 |
Bildungsziel der Schulung:
This seminar informs employees in-vitro diagnostic and medical device companies about the current IVDR regulation and their practical implementation in Switzerland.
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After the seminar, participants will understand the changes brought by the transition from IVDD to IVDR and how the new IVDR requirements are implemented into Swiss law (IvDO) as well as how they are applied in practice.
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The entire lifecycle of IVDs will be covered in this seminar: from conformity assessment and CE marking, through the necessary documentation and product design requirements, performance evaluation, and registration in Switzerland, to the Post-Market Surveillance of IVDs.
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With this knowledge, you will be able to develop your IVDs in accordance with the current requirements, successfully plan the market access to Switzerland, and conduct safety monitoring.
Veranstaltungsort:
Online-Webinar
weitere Orte/Termine
Kursart:
Online-Webinar
Kostenlos Info anfordern
