Cybersecurity in Medical Device Lifecycle

Course description

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, and FDA guidances on cybersecurity are changing software lifecycle processes.

Course outline

• Cybersecurity and FDA, MDR, IVDR and GDPR regulations,
• Secure software development and maintenance according to standards IEC 62304, IEC 81001-5-1 and IEC 60601-4-5,
• Cybersecurity risk management process and interaction with ISO 14971,
• Specific requirements of FDA and content of eSTAR submission on cybersecurity.

Learning objectives

• Knowing the concepts of cybersecurity applied to medical devices,
• Knowing which standards are applicable to cybersecurity in Medical Device 2017/745/EU Regulation and US FDA,
• Understanding how to implement cybersecurity processes compliant to these standards,
• Identifying the differences between EU harmonized standards and UL 2900-1 FDA recognized standard,
• Identifying which documents to submit to the FDA.

Who should attend

• Project managers
• Risk Managers
• Quality assurance specialists
• Regulatory affairs specialists
• Software development teams

Prerequisites

Important prerequisite: Experience in IEC 62304 and medical device regulation for software is mandatory.

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