Cybersecurity is a requirement that is part of the general requirements of regulations 2017/745 / EU and 2017/746 / EU. This is also a requirement of US regulations governed by the FDA. In this training, you will understand how to update the processes of your organization to have your devices compliant with the cybersecurity requirements: risk management, design, development, maintenance, and post-market surveillance. Especially, you will find out how IEC 60601-4-5, IEC 81001-5-1, UL 2900-1, and UL 2900-2-1 are changing software lifecycle processes.
Important prerequisite: Experience in IEC 62304 and medical device regulation for software is mandatory.
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This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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