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  1. Science and Research (Medical Devices)

Software Systems Assured Verification

Software Systems Assured Verification

Contact

Paul Jones, MSCE

Model Based Engineering (MBE) Software Life Cycle Development Process

Summary

The ability of FDA to assess the quality of software in pre and post-market medical devices, and potentially health care systems, depends upon the establishment of quality metrics. Realization of this goal is based on a two-part approach that measures the: (1) development process, and (2) implemented design.

Our research projects encompass:

  • Model based engineering processes (e.g., modeling requirements, model driven testing)

  • Software safety, security, and reliability design analysis using mathematical methods (e.g., formalizing design requirements and hazard analysis, model checking)

  • Software program verification, comprehension, and forensics (e.g., model driven testing, architecture re-engineering)

  • Assurance case presentation methods and procedures for software assessment (e.g., safety, security cases) 

Software is a factor for any medical device (and health care system) that has a computer in it. By establishing software system quality metrics, greater consistency in the review process and confidence in the likelihood of the device performing as intended may be realized.

Major thrusts of research include:

  • Model Based Engineering

  • Software Architecture Re-Engineering

  • Assurance Cases

  • Safety and Security

  • Human Computer Interface

  • Interoperable Medical Devices

  • Body Sensor Networks

  • Mobile App-based Control Systems 

Our assured verification research is cross-cutting, i.e., applies to all medical devices (and health care systems) that use software. 

The following program platforms have been developed to facilitate this research: 

Generic infusion pump – establishes an open system infusion pump platform as a basis for assessing assured verification techniques

  • Interoperable medical device foundation classes – establishes an open system basis for assessing the quality of interoperable medical device systems

  • Body sensor network platform - establishes an open system basis for assessing the quality of body sensor network systems

  • Mobile app platform - establishes a basis for assessing the quality of mobile medical application control systems 

Current funding sources

NSF Scholar in Residence

Personnel

FDA Staff:
Paul Jones, MSCE
Yi Zhang

External collaborators

Arizona State University
Carnegie Mellon / Software Engineering Institute
City London University, UK
DePaul Univeristy
Fraunhofer CESE, University of Maryland
Gdansk University of Technology, Poland
Johns Hopkins University
Kansas State University
Massachusetts General Hospital / Partners
McMaster University, Canada
NASA, NIST, NRC, NSA, DoD
North Carolina State University
Queen Mary University, UK
Stony Brook University
Swansea University, UK
University of Illinois
University of Michigan
University of Pennsylvania
University of Virginia
Vanderbilt University
Washington Adventist Hospital

Resource facilities

Software Reliability Lab

  • Assurance Case Tools

  • Modeling and Verification Tools

  • Security Analysis Tools

  • Static Analysis Tools  

Public domain software

Generic Infusion Pump Project 

Relevant standards & guidance

Standards

ISO 14971:2007 Medical devices -- Application of risk management to medical devices
IEC 62304:2006 Medical device software -- Software life cycle processes

Guidance

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff 

Selected peer-review publications