Description: This course over 3 days will go into more detailed overviews of the processes and deliverables needed for medical device cybersecurity throughout the total product lifecycle. It will help ensure your organization is aware of how to meet regulatory requirements for submissions and the processes to have in place and follow to prepare for inspections.
Event Details:
- Lead Presenter - Matt Hazelett - Chief Operating Officer & Chief Quality Officer
- Date: September 23, 24, and 25, 2025 (4 hours x 3 Days)
- Time: 9:00 AM to 1:00 PM (Eastern Time) Each Day
- Location: Online
Audience: This course is best suited to those who already have awareness of medical device cybersecurity and are interested in a more detailed overview of how to manage medical device cybersecurity over the total product lifecycle. This may include software engineers, cybersecurity staff, regulatory affairs staff, and management.
Planned Agenda:
- Regulation of Cybersecurity – US Focus
- TPLC Security Objectives and Goals
- Concept/Planning
- Security Risk Management
- Design and Development
- Testing – Verification and Validation
- Labeling
- Cybersecurity Management Plan
- Postmarket Requirements – Maintenance