Webinar: Regulatory & Cybersecurity Essentials for medical device software and AI-enabled devices

Shen May Khoo
Webinar announcement poster.

Artificial intelligence is transforming the medical device landscape, delivering unprecedented capabilities in diagnostics, decision support, and personalised treatment.

But with innovation comes complexity. AI-enabled medical devices face heightened regulatory scrutiny and must meet stringent cybersecurity expectations to ensure patient safety, data protection, and market acceptance.

To help manufacturers navigate this constantly evolving landscape, Mantra Systems and Cyber Alchemy are delighted to co-host a joint webinar:

Regulatory and Cybersecurity Essentials for AI-enabled Medical Devices
📅 Date: Thursday, 13th November 2025
🕒 Time: 3pm - 4pm GMT
🔗 Register: Linkedin event page

Whether you are developing a software as a medical device (SaMD), AI as a medical device (AIaMD), integrating machine learning into an existing platform, or preparing for market entry, this webinar will equip you with the knowledge and strategic insight to achieve market success.

Join us to learn how to:

  • Clarify if your software or AI system qualifies as a medical device and its regulatory pathway
  • Understand key regulatory and cybersecurity requirements for AI-enabled medical technologies
  • Build compliant documentation and evidence strategies that support approvals
  • Implement practical cybersecurity and risk mitigation measures while reducing regulatory risk

AI-enabled medical devices are becoming increasingly common, bringing new opportunities, and new regulatory challenges. As these technologies evolve, regulators are placing greater emphasis on transparency, data governance, cybersecurity robustness, and lifecycle monitoring. Devices that fail to demonstrate compliance will face significant barriers to market access.

This webinar will help you stay ahead of the curve, understand regulatory and cybersecurity expectations, and implement practical strategies to achieve and maintain compliance.

Meet the Speakers

  • Simon Cumiskey – Senior Lead Medical Writer, Mantra Systems
    Specialises in regulatory strategy for software and AI-enabled devices. Advises companies on meeting MDR requirements and achieving market access through robust documentation and clear regulatory positioning.
  • Luke Hill – Cybersecurity Consultant, Cyber Alchemy
    Luke is a technical cybersecurity specialist who works across sectors, with a strong focus on MedTech. He has helped bring AI-enabled medical apps to market and worked securing medical devices such as X-ray and MRI systems. His expertise includes security testing, cloud systems, security architecture and application security, translating complex risks into practical, regulator-ready controls.
  • William Brambley - Lead Medical Writer, Mantra Systems
    Develops evidence strategies that secure approvals and drive market adoption. Leads EU and UK MDR submissions for complex software devices, aligning regulatory pathways with commercial success.

To attend, register on our Linkedin event page now.

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