Independent Consultant

Master of Science, Biomedical Engineering

University of Minnesota, Minneapolis, Minnesota

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Mindee has 20 years of extensive experience and expertise in ISO 10993-1 biological evaluations, biocompatibility, toxicology and biomedical engineering. Over the years Mindee has established an excellent track record while contributing to the development, testing and global regulatory approval of new products as well as changes associated with approved products, for Medtronic and Ethicon (J&J). More recently, with the focus on EU-MDR, Mindee’s familiarity and knowledge of the requirements has facilitated successful approvals for a range of medical device applications.

Principal, Chemical Characterization Solutions LLC

Doctor of Philosophy, Analytical Chemistry, Purdue University, Indiana, USA

Post-Doctoral Research, University of Minnesota, Minneapolis, Minnesota, USA

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Dr. Jianwei Li is currently the principal E&L and “chemical characterization” consultant, and chemistry writer at Chemical Characterization Solutions LLC. He worked at Medtronic, a leading global medical device company, for nearly 16 years as a technical fellow and subject matter expert in the chemical characterization (or extractables/leachables, E/L) of medical devices. Over the course of his nearly 30-year academic and industry career, he has published extensively in the area of analytical chemistry with nearly 50 publications, eight of which were devoted to the chemical characterization of medical devices over the last two years. He has worked on more than 200 “chemical characterization” projects, including implantable devices and drug-device combination products; and has more than 16 years of demonstrated “chemical characterization experience” in (a) Testing strategy/program development; (b) Analytical method development and validation; (c) Solvent compatibility and selection; (d) Testing protocol development and execution; (e) Data analysis, interpretation and reviews; (f) LC-MS and GC-MS unknown identifications; (g) Contract lab management; and (h) Regulatory submission support.

Owner/CEO, iDiagnostics Inc.

Doctor of Philosophy, Environmental Health Sciences (Toxicology track)

University of Minnesota, School of Public Health, Minneapolis, MN

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An environmental health sciences and toxicology executive with 10+ years of professional experience in bio/medical/device space, providing consulting/subject matter expert support for a variety of medical devices including combination products. Completed 200+ toxicological risk assessments for Medtronic in support of U.S. FDA and global regulatory submissions for new product development, product change management, manufacturing/field issues, and in response to regulatory inquiries.

Owner, J.B. Stevens & Associates

Doctor of Philosophy, Biochemistry (major), Physiology/Pharmacology (minors)

Cornell University Medical College, New York

March of Dimes Research Fellow – Toxicology. The Toxicology Center, Department of Pharmacology, University of Iowa.

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In 1980, Dr. Stevens joined the faculty of the University of Minnesota in the Division of Environmental and Occupational Health, School of Public Health. He developed the toxicology training tract for the school and over the course of 10 years graduated over 60 master’s degree students, eight PhD students, and trained three post-doctoral fellows. He taught graduate-level courses in basictoxicology, pharmacokinetics, and health risk assessment. He additionally taught courses in toxicology and risk assessment for the State of California Hazardous Materials Management Certification Program. Since1987, in a consulting role, Dr. Stevens has completed over 1000 toxicological risk assessments, in support of new product development, change management, manufacturing and field issues, for various companies.