Cybersecurity and Medical Devices: How to handle it?

Course Identifier:  e00-010

You can find below the full training program. This training is only organized on-demand.


The training objectives are the described below:

  • Present the current challenges related to medical devices and cybersecurity
  • Present the current regulatory requirements with regards to cybersecurity
  • Assess IEC 62443 as a pragmatic alternative to address both procedural, technical and regulatory requirements
  • Propose a roadmap to cybersecurity compliance
  • Increase the cybersecurity awareness for MD business



Our course provides a introduction to Medical Device Regulations focused on cybersecurity aspects followed by the description of a pragmatic approach to handle them according to the authorities recognition. The ISA/IEC62443 standard set (initially developed for generic Industrial and Automation Control Systems Security, recognized by the FDA as applicable for MD) provides a framework to manage the cybersecurity for several customer profiles such as MD providers, MD Integrators and Asset Owners (MD Operators). This course will be essentially focused on the integration of this standard in the current MD lifecycle. The following program will be covered:


  • The new Medical Device Regulation, what impact on software as a Medical Device?
  • Foreseen key challenges with software as medical devices
    • Cybersecurity – what is the problem?
    • Wannacry, what are the lesson learned?
  • Current regulatory status
    • What are the requirements in Europe?
    • What is the current regulatory state of the art?
  • What are the alternatives for cybersecurity management and implementation for MD providers
    • Reference document through multiple application domain
    • UL-2900 as a solution for software aspects of MD
    • ISA/IEC62443 as a solution for the overall scope of MD cybersecurity
  • ISA/IEC62443 – Description of a pragmatic approach to cybersecurity
    • What is the structure of the standard and how to use it
    • Secure Development Processes for MD providers
    • Technical Security Capability of MD
  • What are the opportunities for MD providers
    • Cybersecurity compliance from scratch – A typical roadmap
    • Gap Analysis & Certification process
  • Summary

Cybersecurity and Medical Devices: How to handle it?

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