Medical

Medical technology has seen significant advancements in surgical robotics and diagnostics that utilize AI/ML, revolutionizing patient care. However, these technologies pose significant safety risks if not properly designed and implemented.



At CSL, we address these key challenges by focusing on safe interoperability between devices in complex and evolving care environments, ensuring that innovative technologies that depend on AI/ML are safe for their intended use, and identifying safety risks associated with security vulnerabilities.



We combine our knowledge of relevant industrial standards such as ISO 14791 and ISO 13485 with experience working with advanced technologies to effectively manage safety risks. We provide robust safety solutions that range from hazard and risk analysis to safety requirements definition, and from safety V&V to developing comprehensive safety assurance cases.

Projects

Verification & Validation of Surgical Equipment

Performed verification and validation for a novel technology that uses laser ablation to treat brain tumors.

AI in Medical Devices

Contributed to FDA regulatory approval for an innovative medical device that uses Artificial Intelligence to generate anatomic descriptors from medical imaging data.

Software Requirements for Medical Ventilators

Specified system and software-level requirements for a low-cost ventilator during the Covid-19 emergency.

Verification & Validation of Surgical Equipment

Performed verification and validation for a novel technology that uses laser ablation to treat brain tumors.

AI in Medical Devices

Contributed to FDA regulatory approval for an innovative medical device that uses Artificial Intelligence to generate anatomic descriptors from medical imaging data.

Software Requirements for Medical Ventilators

Specified system and software-level requirements for a low-cost ventilator during the Covid-19 emergency.