Coauthor, the regulatory compliance assistant trusted by medical device software teams, is hosting a new webinar in its MedTech cybersecurity series — this time focusing on the power of threat modelling, a tool often overlooked despite its importance.
Taking place on 30th April 2025, “Threat Modelling: The Foundation of Cybersecurity Success” will offer practical guidance on embedding security into medical software right from the planning phase. The session features Harrison Mussell, founder and Cybersecurity Lead at Periculo, whose deep experience in MedTech compliance includes guiding teams through ISO 27001, SOC 2, EU MDR, and FDA cybersecurity regulations.
Threat modelling plays a central role in the early stages of Software as a Medical Device (SaMD) development, particularly during architectural design and risk evaluation. While it isn’t always introduced at the outset, standards like IEC 81001-5-1 and the FDA’s Pre-Market Cybersecurity Guidance strongly encourage the early adoption of security protocols — with threat modelling as a key component.
“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 at Hindsight Software.
Crucially, threat modelling shouldn’t be a one-time task. As medical software evolves, so too must its security defences. This iterative approach ensures the product remains protected against emerging threats while meeting international standards such as ISO 14971.
Coauthor recently published a whitepaper titled Securing Medical Devices in an Evolving Cyber Threat Landscape, where it highlights the importance of threat modelling in supporting a secure development process. The upcoming webinar builds on this insight, and attendees are encouraged to submit questions in advance to shape a session that reflects real industry concerns.
Key topics will include:
- The fundamentals of threat modelling and when to apply it
- How to align it with ISO 14971 and other regulatory frameworks
- Tips for documenting risks, mitigations, and ensuring traceability
Designed for engineers, cybersecurity specialists, product managers, and compliance professionals, the event is particularly relevant for teams working on SaMD and digital health solutions. The webinar is free but spaces are limited — register now at https://www.coauthor.app/webinars
