Carrie Britton

Britton Medical Consultancy LLC

Carrie Britton

From his LinkedIn:

Over the past twenty-five years, I have honed my expertise in regulatory and quality affairs, with a specific focus on global regulatory strategies, FDA engagements, and compliance with international standards. My experience includes successful regulatory submissions, product approvals, and the development of Quality Management Systems (QMS) that align with both FDA and EU requirements. I have also led cross-functional teams to ensure product compliance and quality, fostering a culture of regulatory
excellence, and driving continuous improvement initiatives.

With a profound commitment to medical device regulation and quality, I manage complex regulatory landscapes, driving innovation and patient safety. My role involves being a communicative force, adept at negotiating and partnering with C-level executives to identify profit-focused opportunities and uphold the highest standards in the healthcare industry.

I am an accomplished regulatory consultant focusing strongly on FDA and EU compliance and strategic guidance for digital health technologies, medical devices, and combination products. With over twenty years of extensive experience, I have established myself as a vital partner for companies tackling the complexities of regulatory pathways, ensuring their innovative healthcare solutions achieve successful market entry. My expertise encompasses a broad spectrum of FDA premarket submissions, including the 510(k) premarket notification process, De Novo classifications for novel devices, and the demanding Premarket Approval pathway. Furthermore, I provide unwavering support for post-market compliance, ensuring my clients maintain regulatory alignment throughout the entire product lifecycle.

I am a leader in quality system management, empowering organizations to implement and uphold robust quality frameworks in line with FDA regulations, including 21 CFR Part 820. My services also include risk management, regulatory strategy development, and preparation for FDA inspections and audits, equipping my clients with the essential tools and confidence to meet and exceed regulatory expectations. By delivering customized solutions and harnessing my comprehensive regulatory knowledge, I enable companies to navigate challenges effectively and accelerate the commercialization of transformative medical products.