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FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

Monday, June 6, 2022 (2:00 PM - 3:00 PM) (EDT)


Everything from common consumer electronics, medical devices, industrial automation controls, and vehicles are becoming network enabled. With so many new devices coming online and so much data being generated, securing the endpoints and their associated ecosystems is a priority for consumers, vendors, and service providers. 

Intertek’s experience with cybersecurity of Medical Devices ranging from surgical robots to hospital monitoring equipment helps our clients eliminate security flaws, meet regulatory requirements and launch successful products. Join Intertek’s global cybersecurity experts as they present a webinar on the “FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” and discuss key issues and considerations for Connected Medical Devices. 

Presentation includes: 

  • Product Life Cycle Cyber Security Measures 
  • Secure Product Development Framework 
  • Threat Modeling Design Phase 
  • Software Bill of Materials (SBOM) Used for Building Safe Connected Medical Devices 


Learn about the speakers: 

Joe Dawson is a Principal Software Security Analyst for Intertek EWA-Canada based in St. John's, Newfoundland. Joe has more than 30 years' experience in Software Development, Data Communications, and Information Security, in both the public and private sectors. He currently sits on the Standards Technical Panels for all the UL 2900 family of standards and sits on one of the IEC 62443 standards committees.

George Strom is Business Development Director of IOT at Intertek, a FTSE 100 Company. George has worked with medical device manufacturers around the world to help them meet all of their assurance, testing, inspection, and certification needs. George’s 20+ years in the Quality Assurance & Safety arena bring insight into the unique challenges of launching a product in today’s Connected World. Prior to Intertek, George worked in Sales and Marketing within the Computer & Office Automation Industry. He is a proud alumnus of U-Mass Lowell and lives in the Greater Boston Area.

Monday, June 6, 2022 (2:00 PM - 3:00 PM) (EDT)
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