In this one-hour webinar, we discuss various aspects of medical device cybersecurity and how attackers develop exploits to attack devices, and how it’s a lot easier than you’d think. We’ll also talk about how you can use this knowledge to more efficiently approach cybersecurity in medical device designs and standards compliance to the FDA Recognized UL 2900 family of standards. This is particularly important for manufacturers preparing to submit new network-connected devices and software into HDO procurement processes and into regulatory processes such as the US FDA 510(k) submission process or to meet other country-specific needs such as those of Health Canada, the MFDS in Korea, or NMPA in China.
- What has happened in healthcare
- How do the attackers do it
- UL 2900 testing to establish a baseline of cybersecurity hygiene
- The relationships among Basic Safety, Security, and Essential Performance
- The role of process standards in UL 2900 testing (ISO 13485, ISO 14971, IEC 80001, IEC 62304)
- QMS, RM, and SDLC processes can be used to address security Weaknesses and Vulnerabilities
- How testing can promote defensive design