Maureen N. Garner
Maureen N. Garner, MS, MT (ASCP), ASQ CQA
Maureen has over 27 years of industry experience in medical device, in-vitro diagnostics, and pharmaceutical firms, specializing in product approvals for diagnostics and devices, with an emphasis on point-of-care and over-the-counter diagnostics.
After beginning her career as a hospital medical technologist, Maureen joined the medical device industry in 1981. She headed quality control and technical services departments, and over the following 22 years, she assumed increasingly responsible management positions in QA and regulatory affairs. Maureen was the Director of Regulatory Affairs at a major pharmaceutical company prior to founding NWRS. Ms. Garner possesses expertise in the preparation and submission of IDEs, PMAs, and 510(k)s for medical devices, as well as in clinical trial monitoring and clinical and GMP audits.
Maureen holds a BS degree in Medical Technology from Fairleigh Dickinson University, a Masters of Science degree in Pharmaceutical Regulatory Affairs from the School of Pharmacy at Temple University, and she maintains her ASCP certification. Maureen’s commitment to quality and continuing professional education was recognized in June 2005, when she achieved Certified Quality Auditor status from the American Society for Quality (ASQ CQA).