Executive Compliance Director
Leah Applewhite is a seasoned Quality & Regulatory executive with 20 years of experience, bringing extensive expertise in Medical Device and In-Vitro Diagnostic (IVD) Devices. She has a proven track record in creating and implementing robust quality management systems, leading critical compliance initiatives, and providing expert regulatory consulting services. Leah is dedicated to ensuring regula...
Experience: 17+ years
Submissions: 25 510(k), 5 De Novo
Leah Applewhite provides regulatory consulting services to clients in:
Boasting an MBA in Project Management from Purdue Global University and a Bachelor of Science in Healthcare Administration, this professional possesses a robust educational foundation. Complementing academic achievements are certifications as a Medical Device Lead Auditor and Six Sigma Green Belt, underscoring a commitment to quality and regulatory excellence. This blend of business acumen, healthcare knowledge, and specialized quality certifications provides a comprehensive understanding crucial for navigating the complexities of the medical device industry.
Certified as a Medical Device Lead Auditor and holding a Certified Six Sigma Green Belt from the American Society for Quality (ASQ), this professional demonstrates a commitment to industry best practices and continuous improvement. These credentials signify a dedication to maintaining high standards and contributing to the advancement of quality and regulatory affairs within the medtech sector.
A seasoned Quality & Regulatory executive with two decades of experience, this professional has consistently driven compliance and strategic growth within the Medical Device and In-Vitro Diagnostic (IVD) sectors. Their career is marked by leadership roles at prominent organizations, where they have been instrumental in establishing and refining Quality Management Systems (QMS) to meet stringent global regulations. They have a proven ability to manage diverse teams, host regulatory audits, and lead product development from conception through post-market surveillance, demonstrating extensive hands-on expertise and strategic oversight.
Leah Applewhite is a seasoned Quality & Regulatory executive with 20 years of experience, bringing extensive expertise in Medical Device and In-Vitro Diagnostic (IVD) Devices. She has a proven track record in creating and implementing robust quality management systems, leading critical compliance in...
With 20 years of executive-level experience and a background in large medtech, Leah Applewhite offers a rare and powerful combination of high-level regulatory strategy and deep quality systems architecture. Her proven track record, including guiding 25 510(k) and 5 De Novo submissions, demonstrates a profound understanding of complex FDA pathways. This expertise is complemented by an exceptional proficiency in building and implementing robust, audit-ready Quality Management Systems, validated by her certifications as a Certified Quality Engineer (CQE) and Medical Device Lead Auditor. For medtech companies, Leah provides a holistic partnership, ensuring not only successful market entry for complex devices like cardiovascular, IVD, and SaMD, but also establishing the foundational compliance and operational excellence required for long-term success.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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