Cybersecurity of Medical Devices and UL 2900
The course will review a set of standards published by UL to address medical device cybersecurity which have been adopted by FDA to help manufacturers support security assurance claims
Course objective and outcome
You will hear about various aspects of medical device cybersecurity and how new standards support evidence based assurance that medical device manufacturers have addressed cybersecurity in their processes and designs. This is particularly important for manufacturers preparing to submit new network-connected devices and software via the FDA 510(k) submission process as well as other regulatory frameworks.
The course will review a set of standards published by UL to address medical device cybersecurity which have been adopted by the US Food and Drug Administration to help manufacturers support security assurance claims.
The UL 2900 standards provide manufacturers with testable and measurable criteria to assess medical device software vulnerabilities and security controls as well as identify security improvements.
- Security design considerations for medical devices
- Key processes for managing cybersecurity through the product lifecycle
- Standards supporting cybersecurity assurance, including a detailed review of UL 2900
Who should attend
- Regulatory Professionals
- Software Developers
- Product Security Engineers
- System Engineers
- Product Managers
- Project Managers
- Product Test or V & V Engineers
- Hospital IT Professionals
- Hospital Procurement Professionals
Anura S. Fernando, Principal Engineer, UL Digital Health
UL Life & Health Sciences