Quality Training

Cybersecurity for Medical Devices & UL2900

Objectives

This course provides in-depth coverage of cybersecurity requirements for medical and network-connected devices, with a focus on regulatory expectations and practical implementation. Participants gain a thorough understanding of relevant standards and guidance, including UL2900-1, UL2900-2-1, IEC 81001, AAMI TIR 57 and TIR 97, ISO 14971, IEC 62443, and FDA/EU regulatory requirements. Through a mix of expert input, working examples, and team-based exercises, the course explores secure development processes, threat modelling, risk analysis, testing strategies, postmarket activities, and documentation for regulatory submissions – ensuring participants are equipped to address cybersecurity across the entire product lifecycle.

Participants will gain practical knowledge of

• cybersecurity methodologies,
• threat analysis techniques,
• and key industry terminology essential for regulatory approval.

The course emphasizes real-world application, supported by expert insights and current regulatory expectations, enabling participants to implement and document robust cybersecurity processes across the product lifecycle.

Delivery:
The course material is delivered over 2 days online session.

Content includes

• Importance of Cybersecurity in medical devices
• Cybersecurity history and regulatory landscape
• Cybersecurity for Software and Hardware
• Data Classification and Categorisation
• Risk Management Concepts for Medical Devices
• Premarket Requirements & Cybersecurity Testing
• Cybersecurity Planning and Threat modelling
• Supply chain concerns

Who should attend

Cybersecurity staff

Hardware/software developers

Product/system engineers

Project leaders

Project managers

Quality engineers

Regulatory staff

This course is suitable for delegates with no prior knowledge of medical device cybersecurity and can be customised for a more experienced audience.

Upcoming dates:

Location

Dates

Online, ignoreEntry

17, 18 September 2025

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