Coauthor, the regulatory compliance assistant designed for medical device software teams, is continuing its series on MedTech cybersecurity with a focus on one of the field’s most vital yet underutilised practices: threat modelling.
Scheduled for 30th April 2025, the webinar entitled “Threat Modelling: The Foundation of Cybersecurity Success” will outline how security can be integrated into medical software right from the design stage. The session will be led by Harrison Mussell, founder and Cybersecurity Lead at Periculo, who has over ten years of experience supporting MedTech teams in meeting standards including ISO 27001, SOC 2, EU MDR, and US FDA cybersecurity guidelines.
In Software as a Medical Device (SaMD) projects, threat modelling is often introduced early in the design process, particularly during architectural planning and risk assessment. While it may not always be employed on day one, key frameworks like IEC 81001-5-1 and the FDA’s Pre-Market Cybersecurity Guidance emphasise the importance of adopting security measures — such as threat modelling — as early as possible.
“Threat modelling is where cybersecurity by design becomes real. It connects the dots between architecture, risk, and regulatory expectations,” said Alan Parkinson, creator of Coauthor and CEO of Hindsight Software.
Rather than being a one-off task, threat modelling should evolve alongside the software development lifecycle, helping teams adapt to emerging risks. This approach not only bolsters security but also ensures alignment with global risk management standards like ISO 14971.
Coauthor’s recent whitepaper, Securing Medical Devices in an Evolving Cyber Threat Landscape, explores how early-stage tools like threat modelling are fundamental to a secure development lifecycle. The upcoming webinar builds upon this foundation, offering a practical guide to implementing threat modelling in real-world MedTech scenarios. Attendees are encouraged to submit questions ahead of time to tailor the session to industry needs.
This expert-led webinar will provide insights into:
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What threat modelling is and when to initiate it
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How it integrates with ISO 14971 risk management frameworks
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How to document threats, mitigation plans, and ensure regulatory traceability
The session is tailored for software engineers, product leads, cybersecurity professionals, and regulatory teams — particularly those working in SaMD and digital health. Attendance is free but space is limited, so early registration is recommended: https://www.coauthor.app/webinars
