Biosketch of Nancy Stark, Clinical Device Group Inc

Description: Biosketch of Nancy Stark. Nancy is a Medical Device Expert in Clinical Reseach and bilogical safety. President of Clinical Device Group, FDA Aproval, Toxicology consulting, PMA and IDE

Keywords: Nancy J Stark, biocompatibility, biological safety of medical devices, training for medical device clinica research, carcinogenicity, chronic toxicity, ISO 10993, risk assessment, risk analysis, member of AAMI, TAG 194, safety test, biosafety, statistics, sample size, biostatistics, substantially equivalent, medical device safety efficacy and performance, statistical plan, clinical database with double data entry, Part 11 compliance, hypothesis, ISO 14155, EN 540, project management for clinical trials, sponsor, protocol, literature, investigator brochure, Cochrane Library, clinical, research, study, trial, studies, response variable, endpoint, case report form, clinical investigator, technical writer, FDA compliance, CDRH, 510k, 510(k) submission, premarket notification, IDE, investigational device exemption, PMA, premarket approval, biomedical, regulatory affairs and quality assurance, competitive intelligence, corporate intelligence, medical market, market research, corporate spy, SCIP, CRA training, Clinical research seminar, medical deviceconference, CRA certification, survey, IVD, in-vitro, in vitro diagnostic, biomedical, biotechnology, biologic, combination product.

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Nancystark.com

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