Content
This half-day advanced seminar focuses on the practical implementation of the requirements in everyday laboratory life. Important steps on the path to IVDR compliance are explained, such as: B. the risk classification based on the intended purpose, the meaning and handling of the basic safety and performance requirements as well as the associated documentation effort. This knowledge helps to identify gaps, set essential priorities and optimally organize project planning.
Both the current findings from applicable MDCG documents and the latest developments from relevant specialist societies will be presented in the seminar.
Topic overview
- Meaning and determination of the intended purpose
- Carrying out risk classification
- Assessment and fulfillment of basic safety and performance requirements (risk management system, state of the art, performance assessment, required verification documentation)
- Issuance of the declaration
- Rationale for in-house IVDs
- Assessment of clinical product experience
target group
Specialists and managers from medical laboratories, employees from quality management and regulatory affairs.
Prior knowledge
The seminar is an advanced seminar, which is why participation in the basic seminar “IVDR – The influence on medical laboratories” is recommended.
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
