Find an Expert
Professional QA & Regulatory Compliance for Medical Devices, Plastics Process Qualification
Expert has over 30 years of experience as a quality improvement professional, providing technical and managerial quality systems management. His base is a select group of processes within which we maintain current knowledge and process engineering skills. He offers full…
Biomedical Engineering; Medical Devices
IP Projects Catheter stabilizing device Dental Instrument Implant Seeds Intrauterine pressure catheter Vascular Catheters (3) Over 30 years experience in medical product design and development experiences in Anesthesiology, Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, Implants, Instruments, IV Systems, Home…
Quality Assurance Engineering
Expert has over 15 years of experience with quality assurance. He provided Quality Assurance support to insure timely and cost effective: systemic, design, component and product compliance. His activities included supporting: New Product Development, Design Reviews, Verification and Validation, Material…
Biomaterials: Biocompatibility, Pathology, Devices
Expert J. Expert is a D.V.M. with a Ph.D. in veterinary pathology. He is also board certified by the American College of Veterinary Pathologists. As part of his Ph.D. research training he was involved in the characterization of several spontaneous…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Medical Devices, Biotech, Aseptic Processing, Engineering, Facilities, and Sterilization
Expert has extensive expertise in all areas of aseptic processing and terminal sterilization of medical devices, human tissue for transplanation processing, microcontamination and controlled environments. He has been involved in clean room projects for Ethicon, Inc., Osteotech, Inc., Manufacturing Automation…
Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
Machinery CE-Marking, Medical Device CE-Marking, CE-Marking with EU Authorized Representative Office
ISO 9000 IMPLEMENTATION; ISO 9000 AUDITING. Expert has expertise in implementing, documenting, and auditing procedures of medium to small companies that are pursuing ISO 9000 certification. Her organization provides training and consulting to implement ISO 9000, with emphasis on minimizing…