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Expert ID: 729752 New Jersey, USA

Expert in Medical Device Design Control and Software Validation

Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design…

Expert ID: 736460 Virginia, USA

Expert in Software Engineering; Building Globally Distributed Engineering Teams

Global software engineering leader with 30+ years of expertise growing large global teams. Deep technical experience in DNS, Domain Name System, Domain Registries, and other networking technologies. Experienced leader at Verisign and Amazon Web Services. A highly analytical and results-oriented…

Expert ID: 726940 Texas, USA

Expert in Software and Computer Systems Legal Consultant and Expert Witness

Expert has a highly successful track record of providing state-of-the-art software solutions on a variety of technology platforms. He has enjoyed great business success and has received multiple achievement awards. As the leader of his group, Expert is truly a…

Expert ID: 734908 Georgia, USA

Expert in IT: Software Consulting, Manufacturing and Supply Chain (Warehouse and Inventory) Management and Traceability, and CGMP

Expert is an operationally focused, multi-disciplined, senior IT professional specializing in the installation and/or project recovery of complex/multi-dimensional manufacturing and supply chain-related systems and equipment. He is highly technically and operationally but with the abilities experiences, and temperament needed to…

Expert ID: 733647 California, USA

Expert in Software, Internet, Data Storage, Data Networking, and Telecommunication

Expert has decades of software development and management experience. He has designed and developed system software, application software, user interface, device drivers, document processing software, firmware, BIOS code, Web software, database software, and other software for a variety of devices…

Expert ID: 732460 Maryland, USA

Expert in FDA Regulatory Expert Witness Regarding Medical Devices, Drugs, Software and Data Integrity

Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Talented in depositions and testimony. Specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions: 1) What did the…

Expert ID: 731170 New Jersey, USA

Expert in Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)

After receiving a Expert in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and development. He collaborated with scientists…

Expert ID: 730847 California, USA

Expert in Forensic Animation, Computer Forensics, Technology Valuation, Software Patents, Copyrights, Nuclear, Aviation, Management

Expert does data recovery from systems and devices, and trace messaging and edits to information. He also does metadata tracing. Expert does video animations of "kinetic events", including shootings, stabbings, vehicle crashes, building collapses, and public transit accidents. He also…

Expert ID: 730387 United Kingdom

Expert in Software – Quality Assurance, Regulatory Affairs and Licensing

Expert has over 25 years experience of delivering software solutions/applications to healthcare industries, including R&D, Manufacture and point-of-care delivery (e.g. hospitals). This includes negotiating the difficult areas of licensing in Europe, the USA and beyond, accreditation and certification to ISO…

Expert ID: 730258 California, USA

Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software

Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…

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