ISO 62304 How to Create a Medical Software Development File?
This webinar will help participants understand what the ISO 62304 for medical software is, and how this standard works. Participants will gain valuable learning of how to apply the ISO 62304 in the medical software development process and how to create a medical software development file.
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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.
Why should you Attend:
You should attend this webinar to understand, what is the ISO 62304 for medical software and how is the ISO 62304 working.
You learn, how to apply the ISO 62304 in the medical software development process and how to create a medical software development file.
Areas Covered in the Session:
Who Will Benefit:
- 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?
- CEO's of companies, which sell to Europe medical software or medical devices with software
- Regulatory Affairs Managers of Companies, which sell to Europe medical software or medical devices with software
- Quality Managers of Companies, which sell to Europe medical software or medical devices with software
- Quality Representatives of Companies, which sell to Europe Medical Software or Medical Devices with Software
- Other Managers, which need to deal with regulatory or quality guidelines or medical software for medical devices with Software
Prof. Dr. Dr. h.c. Frank Stein medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in 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