MEDIcept Inc.
Mary Huebner is a highly experienced quality systems professional with extensive expertise in quality assurance and regulatory compliance, particularly within the medical device industry. Currently serving as a Senior Consultant at MEDIcept Inc., Mary has previously held key positions including Quality Assurance Manager at several organizations such as Cardiac Implants LLC, Nanōmix, JC Medical Inc., and Direct Flow Medical. Throughout these roles, Mary successfully managed quality system processes, trained teams, developed and wrote global quality system procedures, and ensured compliance with various industry standards including ISO 13485 and FDA regulations. Mary holds a B.S. in Microbiology with a Clinical Laboratory Science emphasis from California State University, Chico and a Graduate Certificate in Technical Communication from UCSD Extension.
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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.