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Expert ID: 723903 North Carolina, USA

Expert in 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…

Expert ID: 721780 New Jersey, USA

Expert in Biocompatibility Testing and Biomaterials for Medical Devices

Consulting experience in the set up and protocols for biological tests, pre-clinical evaluation submission summaries (regulatory), product (medical device) cleaning validation, GLP laboratory set up and management, biocompatibility/ toxicilty testing Strategy for the pre-clinical evaluation / toxicity testing of an…

Expert ID: 736154 India

Expert in Food and Beverages, FMCG, Dairy and Milk, Agri-Business, Chemicals, Specialty Chemicals, Pharmaceuticals, Health Care and Medical Devices, Industrial Chemical Ingredients

Expert has 34+years of extensive industry experience, is a Highly Qualified, Senior Professional Consultant, and is well known internationally. He has a Graduate Degree in Agricultural Technology-B.Sc. (Agri Tech); an MBA (Masters in Business Administration) and a Ph.D. (Doctor's Degree…

Expert ID: 736123 Indiana, USA

Expert in 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…

Expert ID: 735392 Virginia, USA

Expert in Biomaterials, Biotechnology, Medical Devices, Polymer Chemistry, Biomedical Engineering, Materials Engineering, Healthcare (regulatory), Intellectual Property Strategy

Expert has more than 20 years experience in biomaterials and medical devices, both in industry and as a university professor performing research. His research has a translational focus, so he has conducted numerous pivotal animal studies related to the fields…

Expert ID: 735076 Massachusetts, USA

Expert in Medical Devices, Diagnostics, Digital Health

Expert has 20 years of leadership experience in medical device/life sciences marketing in small start-ups and Fortune 100 companies. Following an industry career Vice President of Marketing for Oridion (acquired by Covidien) Medical, Director of Marketing for Philips Medical, and…

Expert ID: 735921 Georgia, USA

Expert in 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,…

Expert ID: 732325 Minnesota, USA

Expert in Medical Devices, Business Development, Regulatory Affairs, Project Management

Expert successfully launched over 25 new instrument and disposable medical devices. He developed and managed numerous cross-functional and cross-cultural new product and process teams. He has developed rich experience in team leadership and assembly, grounded in RA/QA fundamentals (RAC Certified).…

Expert ID: 733758 Missouri, USA

Expert in 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…

Expert ID: 732824 California, USA

Expert in Medical Devices and Plastics

Expert has been recognized frequently by upper management for his contributions to groundbreaking product development and launch of medical devices. He has over 24 years of engineering consulting experience in the design and manufacturing of medical devices and FDA investigation…

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