Medical Metrics, Inc.
Kirk Johnson is an experienced regulatory and quality affairs professional currently serving as the Director of Regulatory and Quality Affairs at Medical Metrics, Inc. since June 2019. In this role, Kirk Johnson is responsible for overseeing the regulatory and quality functions, ensuring compliance in medical device manufacturing, and leading submissions for 510(k) marketing clearance and CE marking. Prior to this, Kirk Johnson worked as a QA/RA Manager at AirStrip Technologies from November 2017 to June 2019, focusing on quality management system compliance and preparing FDA submissions. Kirk Johnson's extensive background also includes various roles at Stanbio Laboratory, where responsibilities spanned regulatory affairs, quality assurance, and quality control from December 1994 to March 2017, and earlier positions at DPT Laboratories. Kirk Johnson holds a degree from St. Mary's University, earned between 1975 and 1979.
Medical Metrics, Inc.
Medical Metrics is an experienced, ISO 9001:2015-certified, medical imaging core lab for multicenter clinical trials. We perform independent evaluations of medical images for regulatory filings and post-market publications. Our services include imaging protocol development, expert image analysis, data management, and scientific consulting. Since 2000, we have supported over 700 clinical trials and research studies across a range of therapeutic areas. Approximately a third of our work is FDA-regulated. Another third is international, spanning 50 countries on six continents. We also support pre-clinical and post-market studies resulting in important product advances and scientific publications. Our radiologists and scientists are recognized experts in medical imaging and research. They include editors of scientific journals, presidents of medical societies, department chairs of radiology, division chiefs of surgery, lifetime achievement award-winners, national scientific honorees, and expert advisers to regulatory authorities. Our depth and diversity of experts allow us to support almost every imaging modality in clinical research. No other core lab offers our unique combination of luminary expertise, experienced project managers, ISO-certified quality system, and state-of-the-art platform for data management. In a single provider, we deliver the scientific expertise and leadership of an academic research group combined with the operational strength, global reach, and resources of a commercial imaging CRO.