Cybersecurity isn’t just an add-on to medical device safety—it’s now integral to creating devices that meet both regulatory standards and patient expectations. With expanding FDA guidance, MDR, and IEC 81001-5 requirements, your Quality Management System (QMS) must evolve to address cybersecurity alongside safety.
But don’t worry—updating your QMS doesn’t mean starting from scratch. In our series of 30-minute “Lunch & Learn” webinars, you’ll uncover:
The latest regulatory guidance and its practical implications.
How to seamlessly integrate cybersecurity into your existing QMS.
Actionable steps to create developer-friendly cybersecurity processes.
Why Attend?
Two seasoned experts, Dr. Heather Carre-Skinner (QA/RA) and Alan Parkinson (Software Engineering), bring complementary perspectives to help you:
Comply with new cybersecurity standards without slowing down development.
Implement changes that make a real impact on both safety and security.
What’s On the Menu?
Introduction – February 13th 2025
A Safe and Secure QMS for Medical Devices
Discover what regulations require and how to adapt your QMS:
FDA, MDR, and IEC 81001-5 insights.
Why cybersecurity is safety.
Common myths debunked.
Practical updates to SOPs and plans.
Threat Modelling - Date tbc
The Foundation of Cybersecurity Success
Just as risk analysis is critical to medical device safety, threat modelling identifies cybersecurity risks and appropriate mitigation. If you only have time to implement cybersecurity-related change, then Threat modelling provides the largest positive change.
· What is Thread modelling and when do you need to do it
The differences and synergies between risk management and threat modelling.
Documenting threats, mitigations and traceability.
Software Supply Chain – SBOMs Meet SOUP - Date tbc
Manage Your Supply Chain Risks
Gain clarity on SBOMs (Software Bill of Materials) and their importance:
· What is an SBOM and is it the same as SOUP?
· What needs to be in an SBOM
· Simple ways teams can create an SBOM
· How to use an SBOM to monitor for newly identified vulnerabilities in SOUP
· Mitigating supply chain risks and how it impact’s a medical devices software maintenance
Security Testing - Date tbc
Testing with Confidence
Explore tools and techniques to secure your code:
· Finding vulnerabilities in code with SAST and DAST
· Verification and testing threat model mitigations
· Penetration ‘Pen’ testing – When and how
· Conducting effective security code reviews.
Did You Know?
A medical device isn’t safe if it’s not secure. Cybersecurity isn’t just about preventing network breaches—it’s about protecting device integrity, availability, and ultimately, patient safety.
This series is an opportunity for QA/RA consultants to add value by helping clients update their QMS for cybersecurity requirements, keeping them compliant and secure.
Don’t miss this chance to stay ahead of the curve.
Sign up today and transform your approach to medical device cybersecurity!
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