Epsom, UK. April 24th 2025 – Coauthor, the regulatory compliance assistant for medical device software teams, is continuing its MedTech cybersecurity webinar series with a deep dive into one of the most underused — yet critical — tools in the field: threat modelling.
Taking place on 30th April 2025, “Threat Modelling: The Foundation of Cybersecurity Success” will explore how security can be designed into medical software from the start. The session features Harrison Mussell, founder and Cybersecurity Lead at Periculo, who brings over a decade of experience guiding MedTech teams through standards such as ISO 27001, SOC 2, EU MDR, and US FDA cybersecurity requirements.
In Software as a Medical Device (SaMD) developments, threat modelling typically comes into play early in the design phase — particularly as part of architectural planning and risk analysis. While it doesn’t always begin on day one, regulatory guidance such as IEC 81001-5-1 and the FDA’s Pre-Market Cybersecurity Guidance underscores the importance of introducing security considerations, including 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 at Hindsight Software.
Far from being a one-off exercise, threat modelling should be revisited throughout the software development lifecycle to adapt to new threats as the product evolves. This approach not only strengthens cybersecurity but supports better alignment with international risk management standards like ISO 14971.
Coauthor has recently authored a whitepaper, Securing Medical Devices in an Evolving Cyber Threat Landscape, which explores how tools like threat modelling underpin a secure software development lifecycle. Here, Coauthor reinforces that threat modelling is one of the earliest and most effective ways to identify and mitigate potential risks. The upcoming webinar builds on this thinking, offering attendees an introduction to threat modelling within the context of medical device development. Attendees are also invited to submit questions in advance to help shape the discussion and ensure the webinar addresses real-world cybersecurity concerns in medical device development.
This practical, expert-led webinar will cover:
- What threat modelling is and when to implement it
- How it aligns with risk management frameworks like ISO 14971
- How to document threats, mitigations and traceability to meet regulatory expectations.
Designed for software engineers, product managers, cybersecurity leads, and regulatory professionals, the webinar will be especially relevant to teams developing SaMD or digital health technologies.
The webinar is free to attend, but spaces are limited. Secure your place now at: https://www.coauthor.app/webinars
ENDS