2299 Marine Ave.
Redondo Beach, California 90278

May 09, 2008

Medical Devices Product Development Processes Improvement
- James Jones


An author-proven, classical Systems Engineering with Integrated Product/Process Team (IPPT) approach for new products development is described at the practitioner level. For an example of an unusually complex and software-intensive embedded systems medical device, the LLUMC Proton Beam Treatment Center (PBTC) equipment and software is briefly described. Then, the paper "Systems Engineering for FDA QSR Design Controls Compliance" is presented. Application of some fundamental SysEng processes virtually automates the provision of auditable evidence for project deliverables compliance with the provisions for design controls in 21 CFR 820, the Food & Drug Administration Quality System Regulation. The means to integrate ISO 14971 aligned medical hazard analysis with requirements management for ensuring implementation of necessary risk level abatement is described. Following through on that foundation for design controls compliance, the paper "Verification 'Auditablility' Can Be 'Free'" is presented. Here, application of simple audit support standards assists rigorously proving that requirements verification is comprehensively complete. These include basic requirements writing rules as part of refreshing Systems Engineering 101. The described approach also enables relatively automatic provision of effective requirements verification status metrics based on actual milestones completions (rather than the typical gross estimates) so you, your supervisor, and project management obtain appropriate %Complete values.

Your Presenter: James Jones is the Systems Engineering Manager at Optivus Proton Therapy, Inc. and a member (#1884) of INCOSE. He also is Owner/Principal of ODDS Company, a consulting business he founded to provide practitioner level seminars and educational material on Project and System Engineering processes. He has a B.S. in Business Administration and an M.S. in Industrial and Systems Engineering. He acquired skills in comprehensive, rigorous Systems Engineering during work for several defense corporations. His experience applying those skills to medical devices new product development began with an IV infusion Pumps manufacturer and has expanded greatly with the current employer.

Official Website: http://www.uces.csulb.edu/spin/flyer050908.htm

Added by Ontario Emperor on May 1, 2008

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