WEBINAR · ON-DEMAND
Medical devices increasingly operate within networked, cloud, and internet-connected environments. These devices contain configurable embedded computer systems and are wirelessly connected, and the Internet of Things has significantly impacted medical devices through increased hardware and software integration. Cybersecurity threats to hospitals and medical devices occur frequently and can render both inoperable. This presentation emphasizes that cybersecurity analysis must address independent system components and holistic system performance, and should be considered from the concept phase through the Total Product Life Cycle (TPLC), incorporating both premarket and postmarket approaches.
Key Takeaways
- How IoT connectivity has increased hardware and software integration risk in medical devices
- Why cybersecurity threats to hospitals and medical devices are increasingly frequent
- Analyzing cybersecurity at both the independent component level and the whole-system level
- Applying the Total Product Life Cycle (TPLC) approach across premarket and postmarket phases
Speakers
Chad Kymal
CTO and Founder, Omnex Inc.
Chad Kymal is the CTO and Founder of Omnex Inc. He is the author of seven books and more than 100 papers including several on integrated management systems. Chad is currently on the writing committees for several standards including ISO 26262 (Functional Safety), ISO 9001:2015 (Quality Management), ISO 14001:2015 (Environmental Management), and ISO 45001 (Health and Safety Management Systems). He founded and was the CEO of an Automotive registrar for over 10 years and is familiar with conducting audits, being witnessed for audits, and evaluating auditors and assessors. Chad has spent over 20 years in system, hardware and software development, and is an intacs™ certified Principal Assessor for Automotive SPICE.