MEDIcept Inc.
Sean Yohey currently serves as Sr Director of Quality Systems at MEDIcept Inc. since May 2022, and as a consultant in the medical device and biopharmaceutical industry for SynerGxp, LLC and Open since May 2021 and September 2017, respectively. Previous experience includes Compliance Sr. Manager at Philips from April 2018 to May 2021, and Quality Systems Consultant at Medtronic, where contributions included support for Consent Decree remediation and quality issue assessments. Additional roles involved consulting at BPL Plasma and Fresenius Medical Care, focusing on regulatory compliance and risk management. Earlier positions included Sr Manager of Quality Systems at Haemonetics and a consultant with SynerGxP, overseeing quality and regulatory compliance in various capacities. Sean Yohey holds a B.S. in Biotechnology from the University of California, Davis.
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.