YOUR DEVICE IS SAFE. BUT IS IT SECURE?
THE OVERLAPPING IMPORTANCE OF BOTH SAFETY AND SECURITY RISK MANAGEMENT
Great news! Your medical device product development team followed your safety risk management process to a tee – but did they ensure security risk management was considered in the proper context?
Recent FDA guidance is unambiguous: cybersecurity risk management is required for premarket submissions. Yet the practical question of how to perform security risk management within the framework of ISO 14971, the gold standard for safety risk management, often leaves device teams without a clear answer.
Despite their differences, safety and security risk management aren’t two separate silos. Security vulnerabilities can quickly become safety hazards. A threat that compromises device integrity isn’t just an IT problem, it’s a patient risk.
Is your procedural documentation set up to capture security risks with safety implications?
Does your threat model connect to your safety risk file?
Are you documenting the intersection of the security and safety risks in a way that satisfies both FDA guidance and ANSI/AAMI SW96?
Sage Research + Design helps medical device companies answer these exact questions by evaluating procedural documentation, security risk assessments, and threat models to ensure any cybersecurity risks that carry an impact on the product’s safety are properly documented. We’re here to help you bridge the procedural and technical gap so your submission doesn’t just tell a complete story, but a compliant one.
Are your security and safety risk management processes truly working together? We’re ready to help you find out.
About the Author
Elizabeth Mueller, MS is a Risk and Quality Management scientist at Sage Research and Design. She and the rest of the Sage team are experienced helping a wide variety of product teams incorporate human factors processes and successfully prepare for their FDA or international submissions. The human factors team follows the FDA Guidance and IEC 62366-1/62366-2 and is skilled at conducting and documenting Use-Related Risk Analyses, analyses of users, uses and use environments, heuristic evaluations/expert reviews, formative and validation usability testing and many other HF activities. We are ready to help with medical devices, drug/biologic products, or combination products.
Sage Research & Design provides HF Process & Design Assessments, Start to Finish HF Services (full package or ala carte), FDA Submission Readiness Evaluations and Human Factors Training. Best of all their small nimble team is flexible, fun to work with, and will quickly demonstrate that they truly care about you and getting your MedTech product through the HF submission process! Contact us to learn more.
