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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…

Expert ID: 723903 North Carolina, USA

Expert in Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews

Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…

Expert ID: 736123 Indiana, USA

Expert in Medical Device Quality Assurance and Regulatory Compliance

Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…

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: 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: 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: 728303 California, USA

Expert in Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A

Expert has been the CEO or chairman of seven medical device companies in four countries - four public, three private, and has been a member of the Board of Directors of 10 companies. He is an expert in areas of…

Expert ID: 727428 Massachusetts, USA

Expert in Intellectual Property Transactions,Technology Transfer, Licensing, Software, Medical Devices

Expert is a C-level Business Executive with expertise in high-value/risk intellectual property (IP) transactions; technology transfer and licensing; medical devices and related technologies, software and hardware engineering development. She has extensive experience through full lifecycle program management and product rollout…

Expert ID: 726193 New Jersey, USA

Expert in Medical Device Design and Analysis

He was responsible for providing product data for 510(k) submittals. He was responsible for developing devices and technology for patient gas monitoring devices, cardiac monitoring devices etc. He was responsible for the development of several defibrillators. He was responsible for…

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