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...

Regulatory Affairs Consultant for Medical Devices: Expert in U.S. and Canadian Medical Device Approval ProcessSummaryTwenty plus years working in the medical industry in the areas of regulatory affairs, quality assurance, clinical studies, research and development, test, manufacturing and technical service.Regulatory affairs consultant servicing worldwide providing clients with compliance, submissions and training services to the medical device and IVD Industries.Regulatory ExperienceExpert knowledge of U.S. FDA, Health Canada and the European Medical Devices Directive regulations.Product approval and clearance submissions such as 510(k)s...

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...