Meet our team of experts

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With a proven track record spanning two decades, Adrienne has driven projects in quality, sterilization, and regulatory within the medical device industry. Her extensive knowledge encompasses an array of areas, including quality management systems, design controls, resolution of quality issues, sterilization validation, new product development, regulatory submissions, EU MDR integration, post-market surveillance, risk management, and auditing. Adrienne’s professional network extends across legal manufacturers, start-up companies, laboratories, suppliers, contract manufacturers, and sterilization facilities. This network serves as an asset for Device 2 Market's clients, delivering a range of pragmatic and scalable solutions. At Device 2 Market, we hold a shared vision to act as an extension of your team, bridging the client’s needs with our expertise. Our mission is to facilitate the efficient and compliant journey of medical devices to market.

 Rebecca (Becky) comes with over twenty-one years in the medical device industry with in-depth understanding of ISO 13485 and 17025; medical device, pharmaceutical, and tissue cGMPs; GLP and CLIA regulations. She has developed GXP and ISO compliant quality management systems and has successfully directed company quality resulting in observation free regulatory inspections, state licensure, and maintenance of accreditation.  Becky is experienced with managing regulatory inspections and responses at multiple facilities. She brings laboratory experience in equipment qualifications, disinfection/cleaning validations, sterilization validations, and test method validations. Becky partners with all clients, collaboratively working to ensure the success of the project. 

  With over 15 years of experience in the medical device industry, Jonathan has successfully led regulatory affairs teams, providing strategic regulatory and quality system consulting across a wide range of projects. His expertise includes corresponding and negotiating with regulatory bodies, preparing regulatory submissions, and conducting detailed document reviews to ensure compliance with global requirements. Jonathan has played a pivotal role in numerous successful regulatory projects, including 510(k) submissions, EU MDR compliance, and the development of ISO 17025- and ISO 13485-compliant quality management systems. His extensive experience spans various regulatory pathways, risk-based auditing, and quality assurance, ensuring that medical devices meet the highest industry standards. Jonathan partners closely with clients, leveraging his regulatory expertise to navigate complex compliance landscapes and streamline the path to market.

  Nate is a highly skilled regulatory and quality expert with a strong track record in the medical device industry. With over 15 years of experience, he has supported companies in bringing Class II and Class III devices to market by ensuring compliance with FDA regulations, ISO 13485 standards, and global regulatory requirements.  Nate has led regulatory strategy, risk management, and quality system improvements across various organizations, optimizing processes to enhance efficiency and maintain compliance. His expertise includes Design Controls, supplier quality programs, internal auditing, and product verification and validation. He has successfully guided teams through regulatory submissions, quality system overhauls, and international compliance efforts.  As a consultant, Nate provides tailored solutions to help companies strengthen their regulatory and quality frameworks. His practical, results-driven approach allows businesses to navigate regulatory complexities with confidence while maintaining high standards of safety and performance.