- Consulting Firm – Industry Consultant (2008-present)
Provided expert FDA, MDD, MDR and IVDR device compliance advice and remediation leadership for US and EU clients especially in the areas of device design controls, risk management, device software, SAMD, QS Software including 21 CFR Part 11 requirements, US HIPAA and EU GDPR data privacy, combination devices, process validation, plus EU MDR & IVDR Quality System and product technical documentation. In addition, have a reputation for helping clients under extreme regulatory scrutiny effectively correct existent device product issues. Holds membership with several professional societies including RAPS, AAMI and Reliability Society. In addition, maintained the Regulatory Affairs Certification (RAC) since 2008.
Key example engagements include:
complex leadership roles such as multiple EU MDR assessments and retrospective MDR Quality System and technical documentation gap mitigation, FDA design controls and software SME for consent decrees as well as warning letters including remediation oversight, long term role as acting executive director of heart lung engineering to correct existent device product issues while under extreme FDA scrutiny, third party consent decree and warning letter quality system assessments for design controls and software, design history reconstruction to current US requirements, design corrective action effectiveness assessments, device safety risk assessments for complex devices including software and systemic risks (e.g. medication delivery systems, auto-injectors, defibrillators, CT, interventional X-ray equipment, heart-lung equipment, proton therapy equipment, endo-surgery equipment, nebulizers, blood analyzers, computerized cosmetic surgery, cell phone and information technology based software medical devices).
Other example engagements include:
device and product software safety standards compliance including IEC60601 and IEC62304, product software validation, mfg. process and quality system software validation, software security and data integrity, CAPA root cause analysis, creation of technical documentation for software 510K submissions, 510K submission decision advice, plus nonconformity record, device history record, device master record and design history file effectiveness checks after warning letter remediation to confirm routine regulatory and process compliance.
- Medical Device Technical and Quality Management (1988-2008)
Managed design and quality assurance teams consisting of 20 to 75 personnel with direct responsibility for medical equipment design assurance, device software QA, system engineering, software technical standard compliance, regulatory compliance, reliability engineering and product V&V in medium to large companies such as Picker International, ATL Ultrasound, Hill-Rom and Boston Scientific up to the Global Director Level. Also, provided quality systems gap assessments and redesign leadership to drive changes regarding discipline based design practices such as design controls, V&V, product software validation, 3rd party design sourcing, process validation, product reliability, product safety risk management and software hazards.
Gained invaluable FDA inspection experience that includes large comprehensive post remediation inspections of Design Controls and Process Controls by FDA national experts along with several inspectors. Also, attained FDA 483 free compliance within several major product design organizations that previous obtained multiple FDA Warning letters, and generally had a poor historical regulatory compliance track record.
Provided technical and quality expertise for a wide range of products including: single use catheters, stents, endoscopy equipment, ablation devices, infusion pumps, automatic needle injectors, imaging workstations, nurse stations, medical beds, incubators, medical gas delivery, CT and ultrasound.
Standing member of the Product Safety Committee at two medical device companies.
- Civilian Nuclear Power (1982-1988)
Responsible for design changes, technical support and preoperational testing of the neutron monitoring and rod control systems during the nuclear reactor startup programs at two nuclear plants for General Electric. This included design modifications to electronic, electromechanical and microprocessor based equipment, test procedure development and execution, NRC site inspections, answering NRC regulator questions, as well as the investigation of reported problems. Once my assigned systems completed operational qualification, tasked by the utility to manage the evening shift pre-operational test program.
Gained valuable international experience through a multiyear residency in Switzerland. Promoted twice from engineer (L9) to senior engineer II (L11). Also, obtained basic German language technical reading skills.
- Naval Officer, US Navy (1977-1981)
Commissioned Officer (O-1 to O-3) responsible to ensure the safe and effective operation of a Nuclear Submarine. Officer in charge for diverse submarine divisions, as well as the department head of the Operations and Weapons departments. Attained top 1% performance reviews as well as several personal commendations from Naval command as a leader and naval officer who could be counted on to get the job done even during engagements with US adversaries. Member of a submarine unit that received a Navy Unit Citation and Combat Expeditionary Medal.
TRAINING, EDUCATION and BACKGROUND:
- Bachelor Degree in Physics & Chemistry at University of North Carolina at Chapel Hill, Dec 1976
- Completed the Naval Officers Nuclear Power School graduate engineering curriculum in top tier of the class
- AAMI committee member for IEC 62304, Medical Device Software- software lifecycle processes
- AAMI committee member for AAMI TIR32, Medical Device Software- risk management
- EU MDR, FDA regulation and MDSAP training
- Member of the Regulatory Affairs Professional Society with RAPS Certification (RAC)