Expert Details

Expert in Medical Device Software, Medical Device Software Engineering, FDA Compliance, FDA 501K and PMAs for Software

Expert ID: 724218 California, USA

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Expert has wide range of extensive hands on experience developing and manufacturing medical devices. Over the last twenty plus years he has successfully deployed several medical devices in the cardiovascular, opthalmic, and diagnostic industries. His responsibilities have covered the gamut of full product development, including basic research and development, basic engineering reliability and quality, modeling, optimization, software programming, testing, validation, regulatory submissions and GMP compliance, and manufacturing scale up as well as documenting processes and procedures required by the FDA.

Expert has extensive knowledge and consulting experience in implementing the Good Manufacturing Practices (GMPs), which are also known as the Quality System Regulations (QSRs) for medical device and diagnostic firms. As part of his consulting responsibilities he has assisted various organizations (small, medium, and large) with the implementation of the QSRs as well as 21 CFR Part 11 (Electronic Records and Electronic Signatures). The activities ranged from writing both basic and advanced procedures to cover areas such as Corrective and Preventative Actions (CAPA), Medical Device Recalls, MDR reporting, Management Review, Design Controls, Regulatory Inspections, Servicing, Supplier Certification, etc. to reviewing and tailoring current in-house procedures, providing basic GMP training, and providing GMP/Quality System auditing.

Expert is considered an industry expert in the area of medical device software and medical device software engineering. He has participated in several industry/FDA projects including the creating and reviewing of a software quality assurance method for declaring conformance to AAMI Standard SW68 (Software Lifecycle Processes for Medical Device Software) and the recent AAMI TIR for Validation of Software for Regulated Processes. He also has been trained by the SEI to perform software capability evaluations using the SEI Software CMM and has been trained as an auditor to ISO 9000-3 (TickIt) and has extensive experience in improving software processes in development organizations. His practical software experience covers the entire lifecycle of software development including performing requirements analysis, performing risk/safety and hazard analysis to ISO 14971, documenting software architectures and detailed software designs, coding and implementation, performing and participating in code reviews, planning and executing unit, integration, system and acceptance level testing and performing software maintenance. He has also been responsible for project management activities on software development projects such as writing various project plans, selecting various software tools, developing estimates for size, resources and costs and creating and tracking project schedules and metrics. He has particular strengths in the area of hardware and software validation and software testing having worked with several companies in validating their medical device software. He is considered an expert in the area of software quality assurance and currently serves as a abstract and article reviewer for the Software Quality Professional journal. Expert has also successfully implemented and tailored the medical device GMPs (QSRs) into several organizations that primarily build and development medical device software.


He was responsible for coordinating the software development life cycle and validation activities for a new Class II ophthalmic medical laser to insure it meets the current FDA's Good Manufacturing Practices (cGMP's) and Quality System Regulations (QSRs). Company passed a FDA and California State Health Department facility inspection and design control audit based on supplied deliverables, and the activities and processes utilized as part of his consulting. As a result, the Company received a certificate to sell its medical device in the State of California. Responsibilities and work included:

• Estimated, developed, planned and scheduled software development and validation activities using parametric cost and estimating software programs (Estimate, COCOMO II and Microsoft Project).
• Co-wrote and reviewed the current Software Development Plan, Software Configuration Management Plan, and the Software Verification and Validation Plan for the software project.
• Co-wrote, developed, reviewed, and coordinated the Software Requirements documents.
• Co-wrote, developed, reviewed and coordinated the Software Architecture document.
• Co-wrote, developed, reviewed and coordinated part of the Software Detailed Design documentation.
• Developed code inspection process for safety critical source code modules. Led, participated in and trained development staff in formal code inspections (Ebenau and Strauss method).
• Developed, analyzed, revised and documented the Software Safety and Hazard Analysis including fault tree analysis and failure mode and effects analysis (FMEA) utilizing ISO 14971 (Medical Device Risk Management Standard).
• Developed and wrote the Software Traceability Matrix for the entire software system.
• Developed and wrote the all Software Testing Plans (Unit, Integration, System) for the project.
• Developed and wrote all Software Test Cases for all levels of testing on the project.
• Coordinated all verification activities with the Manager of Software Engineering and coordinated all validation activities with the Laser Physics, Electrical, Mechanical, Manufacturing, and Quality Systems staff.
• Performed state-of-the-art software testing on the GUI interface and hardware system and documented all test results. Developed and implemented corrective action process for software changes and software defects.
• Reviewed all software changes and software bug reports.
• Created and developed software metrics for the entire project.
• Developed and wrote the Software Testing Summaries, Software Problem Report Summaries, Release and Version Summaries and Software Certification for the system software.
• Performed and documented both physical and functional configuration audits on the software system and development process before release.
• Acted as the Technical Software Consultant for the company for the entire project with regards to defining FDA compliant standards and internal processes during development and maintenance.
• Developed and carried out a Project Post Mortem and Project Retrospective after the completion of the project.
1. He was a member of a Volunteer Industry Task Force to Develop a Software Quality Audit Standard for the Medical Device and Diagnostic Industries with Health Industries Manufacturing Association (HIMA, now Advamed) and Food and Drug Administration (FDA) 1998-2002. Committee met at least two to three times a year around the United States and has created a software quality assessment standard for industry guidance.

2. He was review member of a Volunteer Industry Task Force to Develop a Software Validation Standard for computerized manufacturing systems and quality systems with the Association for the Advancement for Medical Instrumentation (AAMI) standards group and the Food and Drug Administration (FDA) April 2003-2006. Committee has created a technical paper (TIR) for industry on the Validation of Software Regulated Processes published through AAMI in 2007.
He provided full technical and regulatory validation support, technical leadership and process consulting for the entire Development Sciences organization (R&D) and for three business lines, which includes Pharmaceutical Sciences, Pharmokinetics/Dynamics/Metabolism, and Drug Safety Evaluation. Participated in a site wide 21 CFR Part 11 Assessment. Over 220 systems were reviewed, documented and assessed. The assessed projects included spreadsheets, analytical laboratory systems, IT systems and global Informatics systems. Involved in site wide remediation of these informatics systems.

He provided internal consulting (software engineering, quality management, GMPs, and regulatory compliance consulting) on several DSi/Ri Informatics projects, including LabWare LIMS (Laboratory Information Management Systems), Chromatography Data System (Waters Millennium 4.0), SSI Cyberlab 2.1 data archive, Blue Mountain Calibration Manager, Batch Record Systems, Clinical Material Tracking system, Import/Export application, Peoplesoft Material Management ERP application, Business/Financial Records systems, Investigational Sciences Database, Global Scientific Warehouse, SOP documentation system, and a Training Management (Click2Learn) system.

He assisted in building, organizing and staffing the DSi and Quality Management organization within Informatics. Served as acting QM manager responsible for 1 employee, 3 contractors and 1 consultant. Activities included providing GxP training, writing departmental and Quality Management SOPs, GMP SOPs, validation plans, validation protocols, and validation summary reports. Participated on the Leadership team for the department providing testing, project management, strategic planning, and quality consulting. Participated on number of global organizations including World Wide Quality Management Team, Global Vendor Audit Team, and the Global Part 11 Team. Acted as Line Head for the Quality Management group. Mentored Quality Management colleagues.

Expert may consult nationally and internationally, and is also local to the following cities: Los Angeles, California - San Diego, California - Long Beach, California - Santa Ana, California - Anaheim, California - Riverside, California - Glendale, California - Huntington Beach, California - San Bernardino, California - Chula Vista, California

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Year Degree Subject Institution
Year: 1982 Degree: BA Subject: Chemistry Institution: University of California, San Diego
Year: 1982 Degree: BA Subject: Biology Institution: University of California, San Diego

Work History

Years Employer Title Department Responsibilities
Years: 1993 to 2018 Employer: (Undisclosed) Title: President and Owner Department: Responsibilities: He provides software consulting and validation consulting in complying with the FDA Good Manufacturing Practices (GMP’s, now the QSR’s) especially with computer-controlled devices, applications and manufacturing processes and with 21 CFR Part 11, Electronic Records and Electronic Signatures.
Years: 1988 to 1993 Employer: (Undisclosed) Title: Senior Scientist Department: Paramax Division Responsibilities: He worked as a scientist supporting advanced development for current and new products. Responsibilities included the application of mathematics and statistics to diagnostic problems.
Years: 1986 to 1988 Employer: Sensor Diagnostics Inc. Title: Assistant Research Scientist Department: R&D Responsibilities: He was responsible for the assembly and physical characterization of a multiple conductivity immunodiagnostic sensor. He also assisted in the research and development of a solid-phase immunodiagnostic instrument and associated reagents.
Years: 1984 to 1985 Employer: Cardiovascular Devices, Inc. Title: Chemistry Technician Department: R&D Responsibilities: He was responsible for the research and development of a fiberoptic carbon dioxide intravascular blood gas sensor. Other responsibilities included general chemistry techniques, fluorescence analysis, silicone chemistry, probe/sensor documentation and manufacturing techniques, participation in protocol design, surgery, blood compatibility animal studies, testing and PC data analysis of engineering models and prototypes, microphotography, and drug interference testing.

Government Experience

Years Agency Role Description
Years: 1982 to 1982 Agency: The National Institutes of Health, National Heart, Lung, and Blood Institute Role: Physical Scientist Specialist Description: As part of the Summer Employment Program, he participated in research that studied the pathogenesis of sudden infant respiratory distress syndrome (SIDS or Hyaline Membrane disease), meconium aspiration, barotrauma caused by high pressure ventilation, high altitude pulmonary edema, and adult respiratory distress syndrome. He was responsible for blood gas analysis (IL 213), acid/base determination and correction, animal anesthesia/euthanasia, Swan-Ganz catheter placement, measurement of FRC, tidal, residual, and minute respiratory volumes, intravenous fluid replacement, chest x-ray exposure and x-ray film development, lung lavage for surfactant, lung sectioning and fixing for histology, animal necropsy, use and calibration of high fidelity pressure transducers, and the operation of a multi-channel Gould optical recorder and Siemans servo ventilator.

Career Accomplishments

Associations / Societies
International Council on Systems Engineering (ICOSE)
Society of Logistics Engineers (SOLE)
Society of Reliability Engineers (SRE)
IEEE Computer Society (IEEE)
Association for Computing Machinery (ACM)
American Society for Quality (ASQ)
Chemometics Society
Independent Computer Consultants Association (ICCA)The Society of Pharmaceutical and Medical Device Professionals (ISPE)
Association For The Advancement of Medical Instrumentation (AAMI)
Regulatory Affairs Professional Society (RAPS)
Licenses / Certifications
American Society For Quality, Certified Software Quality Engineer (CSQE) Cert. No. (Undisclosed)(retired)

American Society For Quality, Certified Quality Auditor, (CQA) Cert. No. (Undisclosed)(retired)

Certified Software Capability Evaluator, Version 2.0 and 3.0 Method Description, Software Engineering Institute (SEI)

Quality Assurance Institute, Certified Software Test Engineer (CSTE) Cert. No. (Undisclosed)(retired)

Qualified by CPP, Inc. to administer the Myers Briggs Type Indicator (MBTI) instrument, ID No. (Undisclosed)
Professional Appointments
Paper Submission and Abstract Reviewer for Software Quality Professional Journal, ASQ Press
Publications and Patents Summary
He has 16 publications, 3 patents, and a contributer to 2 books.

Additional Experience

Training / Seminars
Introduction to Software Retrospectives Workshop

Introduction to Software Retrospectives - An Experiential Presentation

Introduction to the Dietary Supplement GMPs -CFR Part 111
Vendor Selection
CMM Software Assessments for software vendor selection or internal software process improvement

Software Supplier Audits for the Regulated Industry
Marketing Experience
Successfully deployed several medical devices (cardiovascular, diagnostic, ophthalmology) during product development.
Other Relevant Experience
Expertise in dealing with the human aspects of software development and software engineering for individuals, teams and organizations.

Certified in administering Myers Brigg Type Indicator (MBTI) instrument to individuals. Post graduate training in Family Therapy and the Satir Model.

Fields of Expertise

medical device, medical device product development, medical device manufacturing quality control, FDA medical device regulation, Current Good Manufacturing Practice, Good Manufacturing Practice, Food and Drug Administration compliance, Food and Drug Administration regulation, medical regulation, Good Manufacturing Practice training, medical device auditing, 21 CFR Part 11, software engineering, computer software, ISO 9000 implementation for software, ISO 9000-3, ISO/IEC 12207 -- Software Life Cycle Processes standard, medical device hazard analysis, medical device safety, medical software quality assurance, SEI capability maturity model, software engineering process standard, software standard, medical device software, Current Good Manufacturing Practice auditing, software project estimating, respiratory distress syndrome, software process improvement, software architecture, mountain medicine, blood analysis, industry standard, real-time software engineering, disaster recovery, blood flow meter, ISO 9000 training, Food and Drug Administration validation, ISO 9000 auditing, medical device inspection, Medical Device Reporting regulation, medical device reporting, software testing standard, sudden infant death syndrome, in vitro diagnostics Food and Drug Administration code, medical device testing, medical device premarket approval, application development system, 510(k) document, ISO 9000 series quality system standard, ISO 9000 quality system documentation, ISO 9000 registration system, laboratory information management, Malcolm Baldrige National Quality Award requirement, CASE tool, software product quality, software process quality, medical device product improvement, statistical computer software, medical device manufacturing automation, ISO 9000 implementation, software productivity, pharmaceutical quality control, application software, medical device process validation, laboratory information management system, fault tree analysis, object-oriented design, Food and Drug Administration, information technology, object-oriented analysis, medical instrument, software project management, quality control, ophthalmology, object-oriented development, management information system, information science, Good Laboratory Practice, failure modes and effects analysis

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