Medical Devices
Modern medical devices—from implantable monitors to high-throughput diagnostic systems to surgical robots and tele-presense, are naturally complex. They incorporate custom hardware, extensive proprietary firmware, and often rely on significant third-party dependencies and components. Patient safety and outcomes are fundamentally dependent on the security, reliability, and proper functioning of this intricate architecture.
A critical challenge in this highly regulated environment is that design flaws or vulnerabilities introduced during the development process can have catastrophic consequences for patients. Unlike enterprise software that can be easily patched, flaws in embedded medical devices may require extensive, costly, and time-consuming remediation via regulatory submission or even product recalls, posing direct risks to patient care and massive financial burdens on the manufacturer or operators.
Services #
Tetrel offers specialized services to support medical device manufacturers in achieving and maintaining compliance with stringent regulatory standards (e.g., FDA, MDR) and ensuring robust cybersecurity throughout the product life-cycle.
Our experts thrive on discovering and helping you correct security weaknesses in both design and implementation, helping you secure faster time-to-market while delivering the highest level of patient safety and regulatory assurance. Our services span all phases of device development.
Risk Analysis, Threat Modeling, and Security Requirements #
Establishing security and safety requirements is step zero for any product security program. Mapping product feature requirements to their associated security requirements (including a gap assessment) is strongly encouraged early in the product development process.
Design Verification and Validation #
Conducting thorough review and assessment of the hardware, firmware, and software implementation to identify vulnerabilities and ensure adherence to specifications. This includes reviewing everything from low-level embedded code to cloud connectivity and back-end cloud services.
Pre-Market Audits #
Identifying and resolving critical security and safety issues before submission to regulatory bodies is vital. Recently the FDA has begun rejecting applications that have undergone insufficient security analysis. Our depth of coverage is highly tailored to the product and customers have used our guidance to successfully attain FDA 510(k) regulatory approval with minimal friction.
Selected Publications #
A curated list of publications and presentations by our team is provided for your review.