Medical Devices

The CAE approach is used within the medical device sector for safety assurance cases. Technology is crucial in the advancement of healthcare and the FDA, EU and UK regulatory frameworks all have requirements for medical devices.

The Health Foundation Report was produced in 2012, and provides a comprehensive review of the use of safety cases in the industry, aiming to determine how healthcare in the UK could use safety cases in the future.

The CAE approach is commonly used for safety assurance cases for infusion pumps and medical software. The FDA guidance document for Infusion Pumps document was created to prepare the medical industry in pre-marketing submissions for infusion pumps, and it identifies device features that should be addressed through the total product lifecycle. The FDA requires that a safety assurance case is developed for new infusion pumps as part of their 510(k) submission. Similarly, the UK NHS requires that safety cases are submitted for approval of healthcare IT systems.

In addition, the Medical device safety assurance case report produced by AAMI document coincides with the pre-market requirements for infusion pumps, and provides safety case model examples.