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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…
Medical Device Quality Assurance and Compliance, FDA Medical Device Regulations, Quality Management Systems, Lean Six Sigma, Certified Six Sigma Master Black Belt
Expert is an extensively knowledgeable, self-motivated, and result-oriented Biomedical Engineer with an extensive background in quality and reliability engineering. Interested in verifying and validating solution designs, including detailed quality metrics in maintaining quality management systems that support and improve processes,…
Medical Device Failure Analysis, Medical Device Product Liability, Patent Infringement Analysis, Patent Invalidity and Validity Analysis, Patent Claim Construction
Expert has over 20 years in the medical device and electronics industries, with contributions exemplified in the numerous products that were developed under his leadership. These products today are improving the quality of healthcare, in hospitals, sub-acute and alternate care…
New business development & new product applications for domestic & International businesses
Expert is founder and president of an international marketing group. Prior to forming his company, he was a principal of a LLC, Vice President, Sales and Marketing as well as many other executive roles in his career. He has over…
Polymer Science and Engineering, Soft Materials, Responsive Materials, Polymer Blends, Block Copolymers, Biomedical Devices
Expert J. Expert is a Distinguished Expert and Alumni Distinguished Graduate and Undergraduate Expert in the Departments of Chemical & Biomolecular Engineering and Materials Science & Engineering at prestigious State University. He received his B.S. degree in Chemical Engineering (with…
Microwave Heating Technologies and Applications
Expert has 35+ years of experience in microwave heating for consumer, commercial, industrial, and scientific applications. This experience has included engineering and developing standard and custom products, including microwave clothes dryers, vending ovens, single- and multi-mode applicators, batch cavity and…
Medical Devices
Expert has about 10 publications on ablation. He published papers on this area and had grants to develop radio-frequency cardiac and liver ablation systems. He founded and directed a laboratory for medical device testing under IEC standards. Overview of Skills:…
Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Employer. A proven track…
In Vitro Diagnostics Industry Including Clinical Laboratory, Immunohematology & Donor Screening
Expert's 40+ year career has spanned a variety of business disciplines and functions including information management, supply chain management, customer service, new product development, sales, and new business start-up. He began his career at Eastman Kodak Company as a Systems…
Lasers and Electro Optics
Provide R&D, engineering, application, product development, 3rd party technical/service, employee training, due diligence research, safety and regulatory compliance of lasers. electro optics and light based instrumentation. As a laser and electro optic technology specialist I’ve been an ongoing engineering, application,…