Cybersecurity for Medical Devices

Cybersecurity for Medical Devices Training

Course Duration: 3 Days

Cybersecurity for medical devices has become a critical concern as healthcare systems and connected medical technologies continue to evolve. Increasing regulatory expectations and expanding software connectivity require organizations to integrate cybersecurity throughout the medical device lifecycle.

This three-day training provides an overview of cybersecurity requirements for medical devices, focusing on FDA premarket and post-market cybersecurity guidance, Section 524B cybersecurity requirements, and the integration of cybersecurity into quality, software, and risk management processes.

Participants will gain insight into the relationships between regulatory expectations and key industry standards, including ISO 13485, IEC 62304, ISO 14971, ANSI/AAMI SW96, ISO 88001-5, and ISA/IEC 62443-4-1. The seminar also introduces practical approaches for security risk assessment, threat modeling, secure product development, cybersecurity verification activities, and post-market cybersecurity management.

The seminar emphasizes practical application through breakout exercises, case studies, and hands-on activities designed to reinforce learning objectives and provide real-world implementation experience

Learning Objectives

  • Provide attendees with an understanding of medical device cybersecurity requirements and regulatory expectations
  • Explain FDA premarket and postmarket cybersecurity guidance, including Section 524B requirements
  • Introduce the role of ISO 13485, IEC 62304, ISO 14971, ANSI/AAMI SW96, ISO 88001-5, and ISA/IEC 62443-4-1 in medical device cybersecurity programs
  • Provide practical guidance on security risk assessment, threat modeling, and cybersecurity risk mitigation
  • Explain cybersecurity activities related to software development, verification, validation, & secure architecture
  • Demonstrate how cybersecurity processes integrate with quality and risk management systems
  • Help organizations develop effective postmarket cybersecurity monitoring and response processes
  • Equip participants with practical knowledge through breakout exercises and case studies
  • Foster a culture of security within medical device organizations

Course Outline

Day One

  • Chapter 1: Regulatory Landscape for Medical Devices
  • Breakout Exercise 1: Identify Premarket Submission Documentation
  • Chapter 2: Security Risk Assessment
  • Breakout Exercise 2: Develop a Threat Model for a Medical Device
  • Chapter 3: Management System Standards
  • Breakout Exercise 3: Integrate ISA/IEC 62443-4-1 Process Requirements into the Management System

Day Two

  • Chapter 4: Risk Management Standards
  • Breakout Exercise 4: Prioritize Risks Based on Likelihood & Impact, and Identify Mitigations
  • Chapter 5: Software and Medical Devices

Day Three

  • Chapter 6: Software Management Systems
  • Breakout Exercise 5: Design a Secure Architecture for a Medical Device
  • Chapter 7: Postmarket Submission
  • Breakout Exercise 6: Identify Postmarket Submission Documentation
  • Chapter 8: Integrated Quality & Security Management for Medical Products
  • Breakout Exercise 7: Integrate Processes (Using a Process Map)
  • · Final Exam

Who Should Attend

This course has been developed for:

  • Engineers, developers, and quality assurance professionals involved in medical device development
  • Regulatory affairs specialists
  • Cybersecurity experts
  • Risk management professionals

Course Materials

Each participant will receive a seminar manual including breakout exercises and case studies.

Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.

Pre-Requisite

Participants should possess a basic understanding of medical device development processes.

Because this seminar provides only introductory coverage of ISO 13485, ISO 27001, IEC 62304, ISO 14971, Threat Analysis and Risk Assessment (TARA), and related cybersecurity concepts, attendees are encouraged to review applicable Omnex webinars or prior training materials before attending.

Omnex also offers stand-alone courses on these subjects for participants seeking more in-depth knowledge.

Upcoming Training

Provide this course Onsite
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For Implementation Support

Cybersecurity for Medical Devices Training Program is available in multiple locations globally, including the USA, Canada, Mexico, India, Europe, Thailand, Singapore, Middle East and China.

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