Consultant Profiles - Quality Systems
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Elizabeth is a 20-year veteran of the laboratory and medical device industry. In addition to counseling IVD clients, she serves as Alquest’s chief operating officer. Before joining Alquest, Elizabeth was Vice President of quality, regulatory and clinical affairs for Applied Biometrics, developer of advanced cardiovascular and hemodynamic diagnostic and monitoring systems; and Senior Quality Assurance Specialist for INCSTAR, manufacturer of clinical test kits for hospitals and reference laboratories. In these roles, she participated in receiving company ISO 9001, EN 46001, ISO 13485, CMDCAS, European Medical Device and In Vitro Diagnostic Directive Certification. Elizabeth earned her MBA degree from the Carlson School of Management at the University of Minnesota and her BS degree in microbiology from the University of Wisconsin. |
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During his 23 years in the medical device industry, Bruce has submitted over fifty 510(k)s, including a dozen for IVDs. He has an informed and pragmatic view of regulatory strategy, having worked in executive and senior managerial positions in regulatory affairs and quality systems with Bio-Vascular/Vital Images, provider of diagnostic visualization and analysis software; DiaSorin, manufacturer of IVD reagents; and Hypoguard (now ARKRAY), manufacturer of diagnostic assays and instruments. Bruce is a highly skilled regulatory strategist and negotiator, experienced in holding effective pre-IDE meetings and developing workable CLIA (Clinical Laboratory Improvements Amendments) waiver protocols. Dr. MacFarlane earned his BA from Yale University; his doctorate from the University of Pennsylvania; and did post-doctoral work at The Johns Hopkins University. |
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Ann is a highly experienced executive in the realm of regulatory and clinical strategy for diagnostic devices. A medical technologist by education and training, Ann’s roots in industry began with Kallestad Diagnostics. In addition to serving as Alquest’s president, she has counseled numerous IVD device clients in her 23 years in the medical device industry. Ann is widely recognized for devising creative and pragmatic strategies that achieve both regulatory and business objectives. She has obtained many approvals including premarket notifications; IDE applications; PMA applications; IDE and PMA supplements and annual reports; and CE Mark design dossiers. Ann earned her MBA from the Carlson School of Management at the University of Minnesota, and her BS from the College of Saint Benedict in Minnesota. |
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Pam has over 26 years experience in quality control, quality assurance and regulatory affairs for IVDs and biologics. Her product experience includes blood grouping reagents (monoclonals), reagent red blood cells, anti-human globulin (polyclonals), ELISA and RIA assays, ASRs, and magnetic bead technologies. Pam specializes in Quality System and facility audits; corrective action plans to meet QSR (ASR manufacturer and Biologics IVD manufacturers) and biologics QSR/GMP requirements; and regulatory strategies to include pre-IDE meetings, Type C and B meetings with CBER. She has prepared license applications for biologic IVDs to include 13 BLAs, 2 FFMU Submissions, 5 BLA Supplements, and 3 CBE-30s. She also assisted with preparation of an IDE submission for anti-HIV PMA product; and she supported 510(k) submissions for instrumentation, CMV and syphilis reagents, positive controls, and miscellaneous testing kits. While with IncStar/Diasorin, Pam supervised technicians in the QC lab who tested and released radioimmunoassay and ELISA based assay kits for detection of various diagnostic analytes in patient serum, plasma, and urine samples; immunoassays for the assessment of bone and mineral metabolism; and thyroid function and hormones. Pam earned her B.A. in biology from St. Cloud State University. |
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