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"CEOâs of companies, which sell in vitro diagnostic medical devices to Europe"
This course will give an introduction into the new in vitro diagnostic medical devices regulation EU IVDR 2017/746 in the European Union. This new regulation has a lot of new requirements and is also stronger connected to the EN ISO 13485:2016. The understanding of these changes and how to implement changes until May 2022 is essential to receive the new certificates until May 2022. The first key for the understanding and the implementation of the changes is the knowledge about the new .. continue reading requirements for the IVD-products. The second key is to understand, which changes need the quality management system according the ISO 13485:2016, which need more processes under the new IVDR as outlined in the ISO 13485:2016. These not covered paragraphs and requirements must be additional implemented into the quality management system until May 2022. The time is short and immediately actions are required. Without the new certificates your sales activities in Europe are interrupted.
- Introduction into EU IVDR 2017/746 (Overview about this regulation, structure, scope)
- How to deal with clinical data and to approve product performance and safety
- Reporting to authorities (incidents, field safety, corrective actions, changes)
- What are the expectations of European Notified Bodies and Competent Authorities?
- What are the requirements of the new EU IVDR 2017/746?,How work the EU IVDR 2017/746 product reviews
Timings8:30 AM - 4:30 PM (Dec 16) (General)
8:30 AM - 4:30 PM (Dec 17) (General)
Entry FeesPaid Ticket Starts from 1899 USD View Details
5 Exhibitors Estimated Count
Category & TypeConference
Medical & Pharma
Editions16 - 17 Dec 2019 1st Edition
Next edition likely in Jun 2020
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|1899 USD||Attendee Seminar One Registration|