Senior consultant in pharmaceutical and medical devices with emphasis in blood testingPharmaceutical and biotechnology quality assurance and control (QA, QC.)Regulatory compliance, consent decree and FDA batch record reviews-investigations; European audits.Plasma and blood collection centers and computerized donor record files.Blood and plasma quality assurance and control.Pharmaceutical QC methods development and review.Pharmaceutical validation of laboratory methods.Quality systems, quality control laboratory and development of standard operating procedures.Regulatory compliance audits; quality system audits.Vaccine stability, raw materi...

Specialists and expert witness in silicone medical devices and related chemical, physical, and biocompatibility testing to support 510k, IDE, and PMA submissions.Specialists in the characterization and qualification of silicone medical devices.Chemical, physical, and biocompatibility testing to support 510k, IDE, and PMA submissions to FDA, particularly related to silicone medical devices and silicone applied technology.Pre-clinical chemical testing and evaluation.Testing protocol preparation; testing protocols of silicone based medical devices.Mechanical testing for manufacture of implantable silicone devices.Polymer characterization, spe...

Experienced applying mechanical engineering tools to biomechanical applications, including computer aided design, (CAD) and finite element modeling, (FEM) techniques. Medical device evaluation and testing. Laboratory testing for hard and soft tissue, joints and other devices such as artificial limb prosthetics and external fixation devices. Medical device testing. Testing of spinal implants and orthopedic devices for FDA submission. Biomechanical evaluation and fatigue analysis of silicone breast implants.Medical device evaluation and testing.Skilled in mechanical laboratory testing and procedures for hard and soft tissue, joints and ot...

Certified Quality Manager and Electrical Engineer for Medical Device Manufacture25 years of experience related to medical device manufacture, quality and regulatory compliance.Certified Quality Manager, American Association for Quality (ASQ ).FDA 510K development and support and managing FDA 510K submissions.FDA documentation and FDA warning letters.Implementation of ISO 13485 resulting in a systematic quality management system for medical devices.IEC60601-1 consulting for basic safety and essential performance of medical electrical devices.Past medical devices projects include: Diagnostic systems; Ultrasound; MRI; CT; Defibrillator teste...

Past FDA Employee Expert in Food, Drug, and Medical Devices Safety and Regulatory ComplianceFDA inspection and investigation of medical devices, pharmaceutical, biologics and food facilities to enforce the FD&C Act.Conducted international FDA medical device and pharmaceutical inspections in 18 countries.Medical device Quality System and pharmaceutical cGMP regulations and principles.QS regulation inspections of the following types of medical device process technologies: Electronic/electrical, sterile (ETO, dry heat, steam, irradiation), plastic, in-vitro diagnostic, metal CNC machining and a variety of product types.Pharmaceutical cGMP re...

Medical device compliance and validation specializing in blood glucose monitoring devices.Blood glucose monitoring devices.Validation of analytical methods, validation plans for facilities and utilities.Regulatory compliance for diagnostic medical devices, bulk chemicals, liquid therapeutic dosage forms, solid dosage forms and bulk API chemicals.Sterile product processing of small and larger volume parenterals.Fermentation processes and semi-synthetic antibiotics production.Solid dosage product processing and controls.Documentation and archiving and paperless systems.Compliance with CFR 21, Parts 11, 210, 211, 620 and 810.Training in compl...

Medical Devise Regulatory Consultant with Class II and III Implantable Medical Device Experience: Cardiovascular Grafts, Surgical Mesh, Heart Valves, Periodontal Implants, Sutures and LigamentOver 25 years of experience in medical devices.Experienced in all aspects of medical device product development, including design, laboratory and clinical testing, manufacturing, labeling and quality systems.Extensive experience in medical devices pharmaceutical and in vitro diagnostics industries.Extensive experience with Class II and Class III implantable medical devices for cardiovascular grafts, surgical mesh, heart valves, periodontal implants,...

Mechanical Engineer Medical Device Consultant for Endoscopic, Surgery, Devices, Respiratory Sleep Apnea DevicesMedical DevicesMedical device product and process development.Design and development of respiratory devices.Medical device injury analysis.Medical device product failure analysis.Diagnostic, monitoring, sedative and therapeutic drug delivery devices.Laparoscopic and endoscopic surgical devices.Surgical stapling devices and skin stapling devices.Oxygen concentrators.Oxygen conserving devices.Sleep Apnea therapy devices, (CPAP, BPAP devices).Spirometry, spirometers and flow sensors.Compressed medical gas storage and delivery.Design...

Clinical and Legal Nurse Expert Specializing in all Aspects of Medical Device Product Development and Regulatory StrategyProduct development expert in recognition of clinical problems that can generate important medical device solutions that meet or exceed sales expectation.Clinical Research Director for large Maternal Infant Care (MIC) Medical Device Business.Expert in developing claims and regulatory strategy for product development.Patient safety and clinical risk assessment process for MIC portfolio.Risk assessment activities during product development.Planned and directed pre and post-market research projects with more than 60 studies...

Medical Doctor with Expertise in all Phases of the Drug Development Process, Including Medical, Legal and Policy Issues Related to Pharmaceuticals, Devices, and Dietary SupplementsAll phases of the drug development process, including medical, legal and policy issues related to pharmaceuticals, devices, and dietary supplements.Therapeutic areas included asthma, epilepsy, cancer, cardiovascular disease, infectious disease, sleep, depression, and prostate cancer.Drug development initiatives, protocol development, data analysis, review and revision submission materials and manuscripts, safety data review, medical monitoring, and medical review...