Cybersecurity Mandates for Medical Devices

by Chad Kymal published on November 10, 2023

Medical Devices are increasingly connected in networks, cloud and to the internet.

  • Contain configurable embedded computer systems
  • Increasingly interconnected
  • Wirelessly connected

The Internet of Things or IOT has made an equal impact on medical devices where there is an increased amount of hardware and software associated with Medical Devices

Cybersecurity threats to hospitals and medical devices are frequent and have rendered both hospitals and devices inoperable

Cybersecurity needs to be analyzed for a part of the system that acts independently and for the whole system

Cybersecurity is important to consider in the concept phase and also on a continuing basis after release (Total Product Life Cycle or TPLC)

  • TPLC Approach - Premarket & Post market Cybersecurity Approach 

Watch the presentation to know more..


Chad Kymal

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 TC 22/ SC 32/WG 8 for ISO 26262 (Functional Safety), ISO/TC 176 for ISO 9001:2015 (Quality Management), ISO/TC 207 for ISO 14001:2015 (Environmental Management), and PC283 for 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 also evaluating auditors and assessors. He authored and teaches a course for 3rd Party Auditors for Automotive Registrars on behalf of International Automotive Certification Bodies Association (IACBA). This course explains how 3rd Party Auditors audit IATF 16949 in an environment that includes ASPICE, Functional Safety and Product Cybersecurity. He is currently rolling out the course to global 3rd Party Auditors for IATF 16949. Chad has spent over 20 years in system, hardware and software development in various capacities. He assesses and works in automotive system, hardware and software for Agile, ASPICE, and Functional Safety ISO 26262. Chad is also currently an intacsTM certified Principal Assessor for Automotive SPICE.