Skeletal-repair implant manufacturer: worked onsite with team in Switzerland to identify applications subject to validation, related to specific FDA submission. Reviewed software-related quality procedures and proposed revisions to harmonize with company's U.S. division. Developed requirements, test documents, and traceability matrices for several applications used in support of design; assisted with testing where needed, and generated test summary reports.
Diagnostics manufacturer: assisted client in establishing documented software quality system. Worked with team to develop validation documents (requirements, design documentation, test procedures, traceability matrix), trained team in test processes, reviewed test results, and wrote final validation report. Reviewed and updated quality procedures for IT processes.
Dental products manufacturer: guided team (based in Germany) through establishing documented software quality system, prepared initial product risk analysis, and worked with team to document validation of new release of CAD software for designing dental restorations.
Medical device design house: collaborated with another software validation firm on two projects. (a) Therapeutic device: evaluated regulatory assessment documents, reviewed detailed multipart requirements specification to identify testable elements, devised single traceability matrix, completely rewrote software function test, developed detailed error condition test. (b) Portable driver unit for implanted artificial heart: Developed FMEA for software functionality (both main application and low-level device code). Extensively reviewed software requirements, system alarms document, and test procedure document. Developed compliance trace matrices to IEC 60601-1-4, 60601-1-8 (alarms), and 60601-1-6 (human factors). Developed outline for COTS evaluation and documentation.
Software vendor: Helped client create a documented software quality system. Started by framing Quality Manual based on ISO 13485. Assessing company’s software product to recommend 21 CFR Part 11 features (to enhance product’s appeal to pharmaceutical-company customers). Quality system project completed March 2008.
Medical device consulting firm: Evaluated software quality procedures and software documentation for several different medical device clients. Assisted in explaining software development plans to FDA reviewers. (Various projects, 2005 - 2010)
Lyophilization service: Validated software driving two production freeze-drying units, and developed procedure to demonstrate equivalence of data between software-driven data-logger and standalone PC software that reads data files from the datalogger. Validations completed September 2006.
Specialty fabrics manufacturer (vendor to multiple medical device companies): Validated twenty-one software applications employed in manufacturing, development, operations, and the quality system, as part of client's push toward ISO 13485 certification. Concluded March 2007; client earned ISO 13485 certification in May 2007. Conducted further validation work in February 2008, April 2009, and January 2010 (for ISO 13485 recertification).
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