Assurance Cases for Medical Devices
Abstract
Recently the U.S. Food and Drug Administration (FDA) issued guidance to infusion pump manufacturers recommending the use of an assurance case to justify claims of safety. An assurance case is somewhat similar in form and content to a legal case. It specifies a claim regarding a property of interest, evidence that supports that claim, and a detailed argument explaining how the evidence supports the claim. Assurance cases have been used in Europe for more than 15 years to argue safety cases for military, avionics, railway, and nuclear systems. The FDA is the first U.S. organization to officially encourage their use in assessing safety critical systems. This presentation will include a brief introduction to assurance cases, why they are useful, how they are developed, and how they can be used to help assure the safety of medical devices.
Document Details
- Document Type
- Technical Report
- Publication Date
- Apr 28, 2011
- Accession Number
- ADA585574
Entities
People
- Charles Weinstock
Organizations
- Carnegie Mellon University