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Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Electrical Engineering
Expert has broad and deep capability in motors and generators. He knows the design process from the centerline out. He has designed machines with special design constraints. He knows the theories of operation and control, and can specify a machine…
Marketing and Business Development for Manufacturing Companies
With Fortune 500, Mid Cap and Small Company Experience, Expert's experience includes extensive sales/marketing and management with technical product firms serving business-to business markets. His career track includes professional growth through such positions as Sales and Product Engineering Manager; Marketing…
GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…
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…
Construction Safety
Expert has over 40 years' experience in worldwide professional safety. His work experience includes tenure as Corporate Safety and Security Director for four Engineering, Design and Construction Management Firms. This work has involved over 600 worldwide construction projects. Additionally, as…
Permanent Magnet Motors, Generators, Devices and Materials
Expert's primary expertise is in magnetic circuit design and analysis, with more than 25 years of both theoretical and hands-on experience in permanent magnet manufacturing and electric motor/electromagnetic device design and manufacturing. Expert has special expertise in the design and…
Cardiovascular and Thoracic Surgery
Expert has over 30 years of clinical experience in cardiovascular and thoracic surgery. He is experienced in coronary artery bypass, initially performing it with cardiopulmonary bypass, but now doing over 80% "off-pump". He developed the largest beating heart surgery program…
Industrial Valves and Actuators in Piping Systems
Expert has more than 25 years experience dealing with industrial valves and actuators in piping systems - and all the upcoming problems. He is officially nominated by the chamber of commerce / Germany. More and more communication is very important…
Congenital Heart Disease, Kawasaki Disease, Endocarditis Prophylaxis
Expert is a pediatric cardiologist at a large metropolitan pediatric institution for over 40 years. He has served as medical director of pediatric cardiac catheterization laboratory for a number of years until 2006. He has undertaken thousands of diagnostic and…