Janet Michener Whipple, based in northeastern Florida, specializes in Quality and Regulatory Compliance for Medical Devices, In-vitro Diagnostics and Combination Products. With 35+ years of experience, she has a comprehensive background in all aspects of global Quality requirements, Product Design, Risk Management, Supply Chain Operations, Post-Market Surveillance, Audits and Inspections, as well as enforcement response and remediation. Jan works to stay at the forefront of regulatory intelligence and industry best practices to provide pragmatic and optimized solutions for clients.

With a track record of compliance performance and quality management system improvements, Jan created Janet Michener Whipple & Partners, LLC in 2026 to provide Quality and Regulatory consulting services to clients globally. For more than a decade prior, Jan was a Partner at a larger consulting firm where she served as a hands-on consultant, strategic advisor, and business partner. Jan’s responsibilities included serving as interim Head of Quality, leading acquisition integrations, facility start-ups, technical transfers and plant closures, preparation for agency inspections and Notified Body audits, inspection response and Warning Letter remediation, Quality Management System design and improvements, new product introductions, and implementation of the latest standards and global regulations for Medical Devices, In-Vitro Diagnostics and Combination Products.

Prior to consulting, Jan held roles of increasing responsibility and within Beckman Coulter Inc, including management positions in Q.A., Q.C., Quality Systems and Compliance, Manufacturing Engineering, Packaging & Cold Chain Process Development, Supplier Management, Logistics (Warehousing & Transportation), Warning Letter Remediation, Due Diligence, M&A Integration, Value Engineering, and serving as the Management Representative.

Jan received her Bachelor of Science degree in Mechanical Engineering from California State Polytechnic University, Pomona, and her Masters of Business Administration - Organization Management from California State University, Fullerton. She is a Professionally Licensed Mechanical Engineer and has completed several post-graduate and certification programs. In addition, she is actively involved in a number of technical and trade associations in an effort to stay current with regulatory trends and industry best practices.

Today, Janet works in collaboration with other experienced consultants as a part of