Coauthor Webinar to Explore Threat Modelling as Key to SaMD Cybersecurity

Coauthor, the trusted compliance tool for medical software teams, is back with the latest instalment of its MedTech cybersecurity webinar series — this time zeroing in on the strategic value of threat modelling.

Taking place on 30th April 2025, the webinar “Threat Modelling: The Foundation of Cybersecurity Success” will unpack how software security can and should be embedded from the early design phase. Leading the conversation is Harrison Mussell, founder and Cybersecurity Lead at Periculo, who has guided countless medical device firms through key international standards like ISO 27001, SOC 2, EU MDR, and the FDA’s cybersecurity directives.

In SaMD development, threat modelling is often introduced during the architecture and risk planning stages. Although not mandatory from day one, frameworks such as IEC 81001-5-1 and FDA guidance stress the importance of early-stage security integration — with threat modelling being central to that effort.

“Threat modelling is where cybersecurity by design becomes real. It connects the dots between architecture, risk, and regulatory expectations,” said Alan Parkinson, the mind behind Coauthor and CEO of Hindsight Software.

More than just a box to tick, threat modelling should evolve with the software, revisited regularly to address new and emerging vulnerabilities. This forward-looking approach enhances not only product safety but also regulatory alignment with frameworks like ISO 14971.

Building on its recent whitepaper Securing Medical Devices in an Evolving Cyber Threat Landscape, Coauthor will use the webinar to show how threat modelling supports robust, secure, and compliant software development. Attendees can submit questions in advance to ensure real-world issues are addressed in the live session.

Key topics include:

  • Defining threat modelling and identifying the right implementation stage

  • Mapping it to risk standards like ISO 14971

  • Best practices for documenting and tracing threats and mitigations

The event is aimed at software engineers, security leads, regulatory experts, and product owners in the SaMD and digital health sectors. Attendance is free, but capacity is limited — reserve your spot here: https://www.coauthor.app/webinars

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