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Training Objectives:
This training is intended to allow the participants to understand the requirements related to Software in Medical Devices. It involves the regulatory requirements, techniques and standards related to the development of Software for Medical Devices, with a specific focus on Cybersecurity.
Training Content:
By attending this training, you will receive in-depth knowledge on the following topics:
- Key requirements for the commercialization of Software Medical device
- When would I consider Software as a Medical Device?
- How is Software Classified according to the Medical Device Regulation?
- Why and where Cybersecurity is relevant according to Regulation?
- Standards, guidance
- IEC 62304 – medical device software – software life cycle processes, good practices that might help me to reach conformity with the requirements
- How can software be developed in alignment with the Quality Management System?
- How to handle vulnerabilities in a Risk Management process?
- Safety classification according to the IEC 62304.
- Additional guidance with a focus on Cybersecurity:
- IEC 62433 family: relevant parts and how to use it.
- AAIMI TIR:57.
- ISO 27001.
- US guidance.
- Conformity Demonstration:
- Key aspects to guarantee the compliance of cybersecurity requirements for my CE label.
- How technical documentation is generated?
- Can I have a cybersecurity certification?
- Aspects of Vigilance post market concerning cybersecurity.
Training Format:
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment (participants will receive a training certificate)