Cybersecurity in Medical Device Lifecycle and IEC 81001-5-1

7h00

Cybersecurity is a requirement of Medical device regulations throughout the world. The FDA already set their own requirements, with their two guidances on cybersecurity. They also added IEC 81001-5-1 to the recognized standard database. In Europe, the MDCG 2019-16 contains recommendation on how to answer to general requirements related to cybersecurity. And the list of harmonized standards references IEC/TR 60601-4-5 and IEC 81001-5-1. In this training, you will get acquainted with these cybersecurity requirements, how they interact with risk management and software development processes. You will also see the main takeaways on how you can establish your own processes to meet the requirements both for US and EU regulations.

People working for medical devices or in vitro diagnosis manufacturers:

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

• 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.

1. Cybersecurity in FDA, MDR, IVDR regulations,
2. Cybersecurity risk management process AAMI SW96, AAMI TIR57, and interaction with ISO 14971,
3. Secure software development lifecycle according to standards IEC 62304, IEC 81001-5-1 and FDA guidances,
4. Secure software maintenance according to standards IEC 62304, IEC 81001-5-1 and FDA guidances