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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…
Medical Device and Product Development Expert
Expert is a seasoned Engineering Leader with over 20 years of experience in Medical Devices, including Product Development and Product Management. He set up the Global Technology Centre for TE Connectivity and Medtronic in India and has established a Catheter…
Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
Product Development, Mechatronics, Mechanical Engineering, Electromechanical Engineering, Analytical Instrumentation, Machine Design
Expert is an Independent Consultant who advises clients about the Engineering, Design, and Development of complex systems and products. His philosophy is to help clients find the best path for their unique situation. In addition, he is an expert at…
Subsea/Offshore Systems: Design, Manufacture and Commissioning; Fabrication, Mechanical, Electrical, Pneumatic and Hydraulic Applications
The design, manufacture, and commissioning of subsea/offshore systems with vast experience in fabrication, mechanical, electrical, pneumatic, and hydraulic applications. Overview: - Ability to resolve problems efficiently in a professional, prompt, and courteous manner - Ability to work to tight deadlines…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Ultrasound and Sonography: Obstetrics, Gynecology, Abdomen, and Small Parts
Expert is a registered radiologic technologist in radiography and sonography with the American Registry of Radiologic Technologists. This sonography exam includes patient care, physics, abdomen and small parts, and obstetrics and gynecology. She is also registered in abdomen and small…
Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process
Experienced clinical research professional with a demonstrated global leadership in the pharmaceutical and medical device industry. Global organization and oversight of clinical research, QA and regulatory strategies. Leadership in new business development (medical device and medical software development quality management,…
Instrument Design and Development; Medical Devices, In-vitro Diagnostic Instruments; Clinical Laboratory Automation; Project Management; Planning, Scheduling, Budgeting. QSR and Design Control
Expert possesses a 30-plus-year track record managing medical device and in-vitro diagnostics development from concept to successful market introduction. A proven manager, he has accrued significant skills in leading diverse and multi-organizational teams in the successful development of leading edge,…