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...

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...

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...

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 Device Consultant (In-Vitro Diagnostics - ISO 13485, 510k, De Novo, CE, CFR 820) with International Experience in Consulting, Program/Project Management, and Manufacturing510k submissions in medical devices.New business and PMP skills managing multiple international projects.Technical proficiencies and strategic planning to optimize existing products and develop new IVD assays.Risk management: Providing risk management assessments, FMEA - design and process, and developing risk management protocols.Composing and documenting product requirements specific to FDA, CLSI, ISO and CE regulations.Technology transfer.Regulatory activities...

Medical Device, Business and Product Development Expert working in the areas of: Orthopadedics, Biomaterials, Market Analysis, and Technology AnalysisMedical device business development activities such as negotiation of term sheets, contracts and due diligence activities, and technology development from bench top to commercialization, portfolio analysis, identification of new technologies for revenue expansion.Key AreasMedical devicesBiomaterialsPatentsOrthopedicsProject managementExpert Witness ExperienceFor an orthopaedic device case: Submitted detailed analysis of technical information.

Dental and Technology Industry Consultant: Dental Devices, Laser, Intellectual Property, Medical Malpractice, Patent Infringements, Prior Art, and FDA WorkMedical laser technology and product development with specific focus to the Medical Infectious Disease and Dental Surgical industry.Bacterial and fungal elimination laser system.Photobiology technology in the medical and dental industry.FDA Approvals (FDA 510(k). Products: Lumenis, Contact Bone Ablation with Er:YAG lasers and OPUSDUO; OPUSDUO E; OPUSDUO EC, OPUS 20; and OPUS SPECTRUM.FDA cleared and CE Mark approved Onychomycosis Laser System selling world-wide.Dual Wavelength Infrared...

Medical Devise Regulatory Affairs - Audits: ISO 13485, cGMP Part 211, Due Diligence, GCP, (QSIT), (QSR), CAPA , Failure Investigations, FDA- 483 (OOS), SOP, IDE and PMA,Over 30 years of experience in FDA regulated industries.FDA regulatory affairs, quality assurance, and compliance with expert skills in good manufacturing practices and good clinical practices for both the pharmaceutical and medical device industry.Clinical trials for CRO and Phase III trial for a cardiovascular drug.Medical device monitoring studies and site qualification for: Carbon dioxide injector (used by interventional radiologists); angiographic studies of the...