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Brian Pate helps medical device companies achieve efficient and compliant product development processes to produce higher quality and clinically valued products and software. He began his career in clinical research over 30 years ago with the Department of Anesthesiology at UAB developing electronics and software for closed-loop control systems for the automated delivery of medications. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time, embedded systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical.Today, he is a Partner and General Manager with SoftwareCPR®, a general regulatory consulting firm, where he specializes in lean/agile process development, software hazards and risk management, management coaching, and strategic regulatory planning. He also leads ValidationCPR, which provides a variety of V&V services ranging from hands-on V&V testing, test protocol development, mentoring V&V staff, or automated test development.
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General ManagerSoftwarecpr Jan 2017 - PresentTampa, Florida, UsBrian 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. -
PartnerSoftwarecpr 2006 - PresentTampa, Florida, UsExpert 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.
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AdvisorRead-Line Jan 2020 - Oct 2022Read-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. -
ManagerGe Healthcare 2001 - 2006Chicago, UsEngineering 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. -
ManagerBaxter Healthcare 1997 - 2001Deerfield, Illinois, UsSoftware 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. -
Engineering DirectorCriticare Systems 1995 - 1997 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.
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Software Engineer, Project LeaderJohnson & Johnson 1991 - 1995New Brunswick, Nj, UsEmbedded software development, patient monitoring -
Software EngineerCare Systems 1990 - 1991Gaithersburg, Md, Us -
Biomedical EngineerThe University Of Alabama At Birmingham May 1985 - Feb 1990Birmingham, Al, UsClinical 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.
Brian Pate Skills
Brian Pate Education Details
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Mississippi State UniversityBiological Engineering -
University Of Alabama At BirminghamBiomedical Engineering
Frequently Asked Questions about Brian Pate
What company does Brian Pate work for?
Brian Pate works for Softwarecpr
What is Brian Pate's role at the current company?
Brian Pate's current role is Partner and General Manager at SoftwareCPR.
What is Brian Pate's email address?
Brian Pate's email address is br****@****cpr.com
What is Brian Pate's direct phone number?
Brian Pate's direct phone number is +178172*****
What schools did Brian Pate attend?
Brian Pate attended Mississippi State University, University Of Alabama At Birmingham.
What skills is Brian Pate known for?
Brian Pate has skills like Software Hazard Analysis, Agile Methodologies In A Regulated Environment, Safety Risk Management For Medical Devices, Software Design Reviews, Software Process Development, Iec62304 Assessments, Lean Software Development, Mobile Medical Apps, Mapp Verification And Validation, Iec62366 Assessments And Remediation, Embedded Software, Software Engineering.
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