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

• OVERVIEW

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 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.

• LEARNING OBJECTIVES

• 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?

• WHY SHOULD YOU ATTEND

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 you quality management system. You understand in this course how to apply the ISO 62304 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 safety and performance requirements of the medical device regulation. In the technical documentation is required to approve the development process, the support process and the life cycle of medical software according ISO 62304.

• AREAS COVERED

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

• WHO WILL BENEFIT?

• CEO’s of companies, which sell medical software to Europe
• Regulatory Affairs Managers of Companies, which sell medical software to Europe
• Quality Managers of Companies, which sell medical software to Europe
• Quality Representatives of Companies, which sell medical software to Europe

• SPEAKER

Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering & software experience for 25 years, 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, Latin-America

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