This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible. Further the risk management of medical software development. In the European Union is the application of the ISO 62304 for medical software mandatory and part of the essential requirements of the medical device regulation. In the technical documentation is required to approve the development process and the life cycle of medical software according ISO 62304.
- What is the scope of the ISO 62304?
- What are the requirements of ISO 62304 in medical software development processes and the medical software life cycle?
- Which companies must apply ISO 62304?
- How to implement ISO 62304 in a smart way into a medical software development project and in a quality management system according ISO 13485?
- How to use the ISO 62304 in the Post Market Process according ISO 13485 and the EU MDR?
- What are the expectations of European Notified Bodies?
Who will benefit:
- Regulatory Affairs
- Quality Managers
- Quality Assurance
- Project Management