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Medical Device Design Control and Software Validation
Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design…
Pharmaceutical Manufacture and Supply in Startup New Product Companies & Acquisition Integration
Expert has successfully developed and led a diversity of complex operations and projects in a variety of cultures and environments. These range from turnarounds and startups of flagship greenfield operations to cross functional teams in world-wide new product launches, and…
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…
Computer Aided Design, Finite Element Method, Mechanical Engineering, Biomechanics
Expert is the Director of the Medical Engineering Research Group at Employer and a Senior Lecturer in Mechanical Engineering. Since completing her PhD in 2001, she has been applying mechanical engineering solutions to medical problems, mainly in orthopaedics. Expert's research…
Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Life Science, Biotech, Pharmaceuticals: Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Expert has over 20 years of experience in strategic innovation, system building, and delivering value solutions for global markets. His focus is on building infrastructure synergies between science, technology, and finance. As a Strategic Advisor, he has experience with: •…
Regulatory Affairs/Registration Consultancy for Medical Devices/Drugs/IVDs/Food in Indian Market
Expert with a post graduate degree in Chemistry has been part of the team in the CDSCO, Government of India for framing of the Import Registration requirements for Drugs, Medical Devices and IVDs. Expert was the Medical Devices Reviewer for…
ISO 9001, ISO 13485 Aerospace, Medical Devices, Machined and Fabricated Parts, Validations
Expert has written world class mangament systems from scratch including all 4 tiers of documentation. Expert has a track record of supporting flawless registration audits and successfuly implementing systems for small shops and companies that often struggle with such endeavors.…
Life Sciences, Biotechnology, Pharmaceutical, IP, Biology, Patents, Molecular Biology, BD
Expert has a Ph.D and two postdocs in Physiology, Molecular Biology and Genetics. B.S in Chemistry/Biochemistry. Over 25 years of experience (at an executive level and as a consultant) in the Life Sciences industry. Founder and President of a life…