Product Development, Testing & Approval

Course contents

- Design and development of innovative health technologies
- Product development in a highly regulated environment
- CE marking process for Medical Devices, In-Vitro Diagnostic Devices, Combination Products
- Classification of medical devices
- Design control process and documentation
- Requirements engineering in health technologies
- Requirements in Implantable Medical Devices
- Verification and Validation of products and processes
- Typical testing regimen in (implantable) medical devices
- Customer Centric Device Design in Healthcare

Department

Master's Program Medical & Sports Technologies