How to create a medical software development file according ISO 62304?

The medical software is the driver of the digitalization of the healthcare systems and the medical products in diagnostic and therapy. This course will give an introduction on how to develop medical software under the requirements of the ISO 62304, 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 will also be discussed. In the European Union, the application of the ISO 62304 for medical software is mandatory and also, it is a part of the essential requirements of the medical device regulation. In the technical documentation, it is required to approve the development process and the life cycle of medical software according to 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 smartly into a medical software development project and in a quality management system according to ISO 13485?
• How to use the ISO 62304 in the post-market process according to ISO 13485 and the EU MDR?
• What are the expectations of European Notified Bodies?

• Medical software development process
• Medical software maintenance process
• Medical software support process
• Medical software product file
• Medical software usability file

You should attend to understand how the ISO 62304 is working, what are the requirements, and how is the ISO 62304 related to your medical software products and connected to your quality management system. This course discusses- how to apply the ISO 62304 in a medical software development project and how the functioning of the smart application during medical software development and in the post-market process is possible. In the European Union, the application of the ISO 62304 for medical software is mandatory and also, it is a part of the essential requirements of the medical device regulation. In the technical documentation, it is required to approve the development process and the life cycle of medical software according to ISO 62304.

• CEOs of companies who sell medical software to Europe
• Regulatory Affairs managers of companies who sell medical software to Europe
• Quality managers of companies who sell medical software to Europe
• Quality representatives of companies who sell medical software to Europe

Prof. H.C. Frank Stein is a medical engineer, medical engineering, & has software experience for 25 years. He has clinical and research experience in tissue engineering, electrophysiology, cardiac surgery, and cardiology, industrial experience in IVD, ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project, and regulatory consulting experience in Europe, North America, Asia, Australia, Arabic countries, and Latin America.