MEDIcept Inc.
Henry Hidalgo is a seasoned professional in quality assurance with extensive expertise in various aspects of quality management systems, regulatory compliance, and microbiology. Currently serving as a Senior Quality Assurance Consultant at MEDIcept since June 2018, Henry specializes in CAPA system management, complaint handling, sterilization validation, and electronic QMS validation, among other areas. Previous roles include Quality Systems Manager at Corindus Vascular Robotics, Senior QA Manager at VYGON, and Senior Manager of Microbiology & Sterility Assurance at ConforMIS, Inc. Henry's educational background includes a degree in Mechanical Engineering of Technology from the University of Massachusetts Lowell and a Bachelor's in Biochemistry from Salem State University.
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MEDIcept Inc.
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MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions. We are an international medical device, IVD, combination product, and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost-effective Regulatory, Quality, Clinical, Auditing, and Educational services. Our experienced team of former FDA, Notified Body, and industry experts will work with you to efficiently develop or remediate a quality system, create a regulatory strategy, or establish a clinical trial, to meet your specific needs. MEDIcept will help you navigate the complex FDA and international regulatory pathways, reduce business risk, and decrease time-to-market while maximizing your potential for success. Every client and every issue is unique. We customize our solutions to fit your needs. With a retention rate of over 90%, we can promise that you will benefit from working with us.