Brian Pate Email & Phone Number

Tampa, Florida, Us

Brian is a Partner and the General Manager at SoftwareCPR® - experts in FDA regulation (and EU certs) and regulatory affairs, and recognized worldwide for software expertise. At SoftwareCPR®, Brian has provided training internally for FDA, and serves as primary faculty for the AAMI/FDA courses on Software Regulation and the Effective Application of Agile Methods course. He also taught the AAMI Design Controls course in 2015. Brian served on the AAMI TIR working groups for TIR 32 (Medical device software risk management) and TIR45 (Guidance on the use of AGILE practices in the development of medical device software). He has a long track record with helping medical device companies achieve lean, efficient, and compliant processes for software development.In addition to Brian's consulting and teaching roles, he oversees day to day operations including marketing, sales, and executive management of the company.

Tampa, Florida, Us

Expert consulting management, audits, assessments, workshops, and training for medical device companies. Specialize in quality systems, design controls, and software both for US FDA and EU regulations/standards (ISO13485, ISO14971, IEC62304, and IEC62366). AAMI Instructor for the compliant use of agile methods course. SoftwareCPR® provides full service regulatory compliance support for Medical Device Manufacturers including quality systems development, submissions, risk management and technical files as well as validation services for Pharmaceutical companies. Training and consulting can also be provided in Chinese, Italian, and Spanish languages.

Read-Line improves building maintenance efficiency and safety by making current, as-built information ubiquitously available, easily updatable, and socializable at any point in a building’s life cycle.

Chicago, Us

Engineering Design Manager, SubAcute Monitoring Solutions Manage multi-discipline, global engineering team in the development of microprocessor based patient monitoring equipment for the SubAcute care areas of the hospital. Develop processes and procedures for the control and management of design methods and practices. Explore innovation opportunities and facilitate advanced development for montoring products.Program Manager, Sub-Acute Monitoring & Perinatal Monitoring Managed local design team and global operations teams through three development projects for enhancements and obsolescence changes to existing monitors.

Deerfield, Illinois, Us

Software Manager and Software System Engineer, Hemo Instrumentation Software Systems Group Designed and developed real time, embedded applications in C, Pascal and C++ for a hemodialysis instrument with over 150,000 LOC. Led nine member software development team in the development of major level of concern, safety critical software.

 Directed new product development for sub-acute and ambulatory monitoring environments. Secured and managed outside contracts for software, electrical and mechanical development in excess of a half million dollars. Managed group of twenty-two engineers/technicians.

New Brunswick, Nj, Us

Embedded software development, patient monitoring

Gaithersburg, Md, Us

Birmingham, Al, Us

Clinical research. Development of custom medical devices to support clinical research, including electronics and software. Key projects included a computer controlled closed loop anesthesia delivery system, airborne casualty evacuation oxygen control system, custom ventilator systems, and gas uptake patient simulators.

B.S., Biological Engineering

M.S., Biomedical Engineering