University of California, Irvine
Institute for Software Research (ISR)
is proud to sponsor the

Software Process Improvement Network (SPIN)

Medical Device Software Development

Friday, October 29, 1999

9:00 a.m. - 12:00 noon
McDonnell Douglas Auditorium
University of California, Irvine

There is a $15.00 charge for non-sponsors.
Checks should be made payable to UC Regents.

No reservations required.

Medical Device Software, the CMM and the PSP
Jean Tyson, Ph.D., Tyson Consulting,

The CMM approach to guiding software process improvement and to evaluating software development capability has spread widely into the commercial software sector over the last ten years. This presentation will map the current FDA regulations for medical device software to the CMM. Three questions will be addressed: (1) Would a Level 3 company be compliant with the FDA regulations? (2) At what CMM level(s) would an organization be rated if its products were compliant with the FDA regulations? (3) What might the CMM community leverage from the FDA approach?


Jean Tyson has 18 years of experience in software development for medical instruments at Beckman Coulter, Inc. Her responsibilities ranged from software developer, to software project manager, to software process group lead. Currently Dr. Tyson is working independently providing training and consulting in software process improvement. She is an SEI-authorized instructor for the Personal Software Process (PSP). Dr. Tyson has a B.A. in Mathematics from Occidental College and a Ph.D. in Molecular Biology from UCLA.

The FDA and Medical Device Software: Past, Present & Future
Carl R. Wyrwa, SQA Manager, Beckman Coulter, Inc.,

Developing high quality software for use in medical devices is critical to ensuring patient and operator safety. Firms developing medical devices that contain software are working more closely with the Food and Drug Administration (FDA) in order to understand and satisfy established regulations that apply to their products. This presentation will (1) provide a summary of the cooperative efforts that are taking place between industry and FDA to further the understanding of FDA expectations related to software development. It will (2) provide an overview of the regulations, guidance documents, an on-site FDA inspection strategies that apply to medical device software development and address the question of "What is the FDA really looking for?" Biography:

Carl Wyrwa is the manager of Software Quality Assurance at Beckman Coulter, Inc. in their Clinical Systems Development Center in Brea, California. Beckman Coulter, Inc. develops and manufactures medical instruments and reagents that analyze patient blood and body fluids for diagnosing disease states. He has been with Beckman Coulter, Inc. for more than 24 years. He has over 21 years of experience in managing and developing software for use in medical devices and previously held the position of director of software development for the majority of the diagnostic instruments developed by the Clinical Systems Development Center. He has also held the position of director of management information systems from 1993 to 1995, responsible for the corporation's worldwide information systems and services organization. He is an active member of the Health Industry Manufacturers Association (HIMA) Device Software Task Force. Mr. Wyrwa has a B.S. in Information and Computer Science from the University of California, Irvine.

Coordinator: Leitha Purcell, Northrop Grumman,

UCI Maps and Directions to meeting are available.

Next Meeting:

Date: Friday, December 3, 1999
Panle Topic: The Effect of Corporate Mergers and Teaming on CMM-Based Cultures:
                        Will this Takeover Impact our CMM Level?
Coordinator: George W. O'Mary, The Boeing Company, george.w.o'
The Institute for Software Research (ISR) wishes to thank its corporate sponsors:


The Boeing Company * IBM * Microsoft Corporation * Northrop Grumman Corporation
Raytheon Company * Sun Microsystems * TRW


FileNet Corporation * Printronix, Inc.
Continuus Software Corporation * Hewlett-Packard

For further information on SPIN or ISR,

contact Debra Brodbeck at (949) 824-2260,

Institute for Software Research
Information and Computer Science
University of California, Irvine CA 92697-3425