- The product development process showing the correlation of regulatory requirements, project activities and deliverables
- Steps in CE certification according to the IVDR, using applicable harmonized standards
- Quality Management System based on ISO 13485
- Extensive explanation of ISO13485 procedures with examples on how to apply this to your own organization, and how this influences the work of your engineers
- Safety Risk Management according to ISO 14971
- Verification and Validation, including the analytical performance requirements of the IVDR
- Usability Engineering
- Performance Evaluation and it's three pillars: scientific validity, analytical performance, and clinical performance
- Extensive explanation of IVDR technical file requirements and supplementary information from applicable standards
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