Accession Number:

ADA585574

Title:

Assurance Cases for Medical Devices

Descriptive Note:

Corporate Author:

CARNEGIE-MELLON UNIV PITTSBURGH PA

Personal Author(s):

Report Date:

2011-04-28

Pagination or Media Count:

53.0

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.

Subject Categories:

  • Medicine and Medical Research
  • Manufacturing and Industrial Engineering and Control of Production Systems

Distribution Statement:

APPROVED FOR PUBLIC RELEASE