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Why You Should Choose a CRO with ISO 13485 Certification for Your Diagnostic Device Development
Introduction The field of diagnostic devices is complex, highly regulated, and fundamentally vital to public health. When designing, developing, and commercializing a new diagnostic product the stakes are high. Partnering with a CRO that holds an ISO...
The Role of ISO 13485:2016-Certified QMS in the Lifecycle of a Diagnostic Device
Introduction The development and commercialization of diagnostic devices are a complex endeavor that involves a multitude of steps, from the initial conceptualization to market launch and post-market surveillance. Given the critical role diagnostic devices play in...
Bergein Overholt, M.D.
Dr. Bergein Overholt is widely recognized for his work as the developer of the flexible fiber sigmoidoscope-colonoscope in 1963, which is used in colonoscopy while serving in the Cancer Control Program of the U.S. Public Health Service. For his innovative work, he was...
Herbert A. Fritsche, PhD
Dr. Herbert Fritsche is Professor of Laboratory Medicine and Chief of the Clinical Chemistry Section at The University of Texas, M.D. Anderson Cancer Center in Houston, Texas. During his 40+ years at M.D. Anderson Cancer Center, Dr. Herbert Fritsche has focused his...
Eric Allyn
Eric Allyn will be a non-Director Board Observer and is the former Chairman of the Board of Directors of Welch Allyn, Inc, a company owned by the Allyn Family for 100 years. In September of 2015, as a result of tremendous consolidation in health care, Welch Allyn sold...
Tom Boyd
Tom Boyd will be a non-Director Board Observer and is the former Chairman of the Company. Tom Boyd was a member of the Company’s Board of Directors since it was incorporated in April 2005, and was the Company’s Chief Executive Officer from April 2005 to April 2014. He...
Paolo Rubatto
Paolo Rubatto is the founder of Start Capital, a London-based early-stage investment firm that invests globally. In addition, he is a co-founder and general partner at Beyond Ventures and an advisor at ScalingLab. Paolo has invested in and advised numerous technology...
Scott Gucciardi
Scott Gucciardi is a Senior Vice President of Solutions at Nextgen Healthcare (NASDAQ: NXGN). Scott Gucciardi is an executive and entrepreneur with over 25 years of experience in the global medical device and health information technology solutions markets. Scott...
Autumn R. Anfang
Autumn Anfang is a highly experienced financial executive with over 25 years of leadership experience in various sectors including for-profit, non-profit, and higher education institutions. She currently serves as the Vice President of Business and Finance and Chief...
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