The workshop conveys legal and regulatory requirements for the design and development process. It takes into account the requirements of EN ISO 13485:2016 and regulation (EU) 2017/745.
The implementation is discussed using the concrete procedure for a design and development project with its phases and their documentation. Aspects of software life cycle (according to EN 62304), risk management (according to EN ISO 14971), and usability (according to EN 62366) are discussed.
- Legal and regulatory requriements for design and development of medical devices
- The design and development process and its phases
- Documentation requirements
- Software life cycle according to EN 62304
- Risk analysis and usability
- Design validation and clinical evaluation
- Change management