Course ID: 145
Course Description:
This course provides a clear and comprehensive understanding of the EU regulatory model. It focuses on key principles essential to both ensuring the safety of medical devices and bringing them to market efficiently.
This course covers the following topics:
- EU directives
- Key players, definitions, and classifications within the EU Regulatory System
- Conformity assessment procedures
- Quality system requirements and evaluations using ISO 14155 (including directives 93/42, 90/385, and subsequent updates)
- Related product-specific directives
- Combination product requirements
- Interactions with directives for pharmaceutical products
- Tissue engineering products
- Additional products taken from the demarcation guide
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