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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…
Network Architecture and Design; Business Systems Based on Networks, Voice, Video, and Data
Expert is a creative architect of large and complex networks for voice, video, and data. He has provided solutions for legacy protocols and applications as well as the latest transmission and switching technologies. Expert has garnered extensive experience in product…
Technology (IT) Related Projects: Implementation, Operations, and Services
Expert has lived and worked around the globe, enriching his life tremendously as well as given him significant experience advising and/or delivering on large-scale technology endeavours working for various large corporations and giants in the industry or their clients. Over…
Telecommunications; Mobile/Wireless; Intellectual Property Infringement/Piracy; IT; Patents; Tariffs
Over 40 years in the telecommunications industry with experience of fixed lines, mobiles, numbering, number portability, IP Telephony, VoIP, WiFi, transmission networks (SDH, MPLS, etc.), IP networking for voice/video, Microsoft Lync services, tariffs (including rental and call costs), PBXs and…
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…
wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…
Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials design and management, community-based research, educational programs’ development and…
Real-Time Embedded Control Software
Experience and expertise is in real-time embedded software and its development, IP, training and support. Having experience working with small to mid-sized companies in communications, automation, consumer electronics and automotive industries, Expert has participated in many facets of business, obtaining…
Medical Device Technology, Molecular Biology, Virology, Infectious Diseases, Tissue Engineering
Expert is a Clinical Trials manager in the National Health Service, UK; where she is involved in Stroke trials. She has had significant experience in the area of Tissue engineering and Stem cell biology for the last 5 1/2 years…
Internet, Telecommunications, Software, Protocols, and Regulations
Expert is a recognized expert in Internet standards, having written a number of standards in the IETF, including a number of SIP (VoIP), peer-to-peer, cloud computing, and messaging standards. In addition, he chaired a number of work groups developing Internet…