Experience

SoftwareCPR

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Partner

  • Jan 2019 - Present

  I am now a partner at SoftwareCPR® where I get a chance to provide High Impact Software Compliance Science Services as well as regulatory advice and guidance to the industry. SoftwareCPR® consists of several partners who are experts in FDA regulation (and ISO standards) in general, and medical device software in particular. Most of our partners and affiliates are former practitioners – they were in the trenches at one time developing and/or qualifying medical devices and the software associated with those products. Our experience ranges from deeply embedded software to SaMD running on standard platforms, from complex control algorithms to user interface graphical software, and from the test lab to the executive board room. We have many years of experience – most of our partners have been in this industry for over 30 years! “Well-seasoned,” we like to say. We can get to the core issues quickly and save you time and money. We do not use a one-size-fits-all approach – we seek first to understand our clients’ culture, what makes their products unique, and how quality assurance already exists in their DNA. SoftwareCPR® is best known for software, regulatory, risk management, validation, and 21 CFR Part 11 consultation for medical device, pharmaceutical, and blood establishment computer system manufacturers. We also provide full FDA enforcement action crisis recovery, premarket submission, and quality system training and consulting services with a focus on client culture, business goals, and efficiency as well as device safety and effectiveness. SoftwareCPR® provides full-service regulatory compliance and premarket submissions support for Medical Device Manufacturers including quality systems development, risk management – including for Health IT and Standalone Software, Human Factors and usability engineering, as well as hands-on quality system automation and medical device validation services for Pharmaceutical and Medical Device companies. Show less



US Food & Drug Administration

• Law Enforcement
• 1 - 100 Employee

• Software Compliance Expert

  • Mar 1994 - Dec 2018

  I spent 25 years at the FDA working on software compliance, software engineering, software safety, software regulation, software guidance and the new Digital Health frontier. My entire FDA career focused on the regulation of software: device software, manufacturing software, quality system software as well as Part 11. I worked software related issues across four parts of the agency: Medical Devices; Drugs; Biologics, including Blood Banks; and the Office of Regulatory Affairs, the agency’s inspectional arm. I retired from the Agency in January 2019. Show less



Technology Management & Analysis

• Systems Engineer

  • Jun 1992 - Mar 1994

  System and Software Integration Engineering for multiple systems onboard the new construction of the multipurpose amphibious assault ships of the WASP class. System focus on aviation, navigation, fire control and communications. System and Software Integration Engineering for multiple systems onboard the new construction of the multipurpose amphibious assault ships of the WASP class. System focus on aviation, navigation, fire control and communications.



General Dynamics Electric Boat

• Defense and Space Manufacturing
• 700 & Above Employee

• Electrical Engineer

  • Apr 1987 - Jun 1992

  Software and System engineering work focused on conversion of analog systems to computer and software-based systems. Systems included temperature and pressure monitoring, automated test focused on performance monitoring and fault location, Tactical Weapon Simulators and unmanned underwater vehicles. Software and System engineering work focused on conversion of analog systems to computer and software-based systems. Systems included temperature and pressure monitoring, automated test focused on performance monitoring and fault location, Tactical Weapon Simulators and unmanned underwater vehicles.



Telex Computer Products Inc

• United States
• Telecommunications

• Field Service Engineer

  • Dec 1980 - Jul 1985

  Serviced and repaired Telex Computer Systems at high profile clients of the US Government in and around the Washington DC area. Clients included CIA, FBI, Joint Chiefs of Staff, US Army, US Marines and US Navy Serviced and repaired Telex Computer Systems at high profile clients of the US Government in and around the Washington DC area. Clients included CIA, FBI, Joint Chiefs of Staff, US Army, US Marines and US Navy



US Navy

• United States
• Armed Forces
• 700 & Above Employee

• Electronics Technician & Reactor Operator

  • Oct 1974 - Oct 1980

  Served as an Electronic Technician and Reactor Operator. Operated and Maintained systems onboard Nuclear Fast Attack Submarine USS Swordfish. Systems include the Nuclear Reactor & primary systems, the reactor plant instrumentation system, radio and navigation systems. Served as an Electronic Technician and Reactor Operator. Operated and Maintained systems onboard Nuclear Fast Attack Submarine USS Swordfish. Systems include the Nuclear Reactor & primary systems, the reactor plant instrumentation system, radio and navigation systems.