In 2013, we embarked on a journey into the world of consulting within the Medical Device Industry. This decision was driven by a profound passion for innovation and a vision to contribute to the advancements in healthcare technology. After gaining valuable experience and insights over several years, we made the transition to full-time consulting in 2018. Our decision to take this step was fueled by a commitment to providing dedicated and focused expertise to clients, enabling them to navigate the complexities of the industry with precision and achieve their goals. We believe that by aligning our knowledge and experience with the needs of the Medical Device sector, we can collectively create a healthier and more promising future.
At Device 2 Market, we are driven by a steadfast mission to lead and inspire transformative progress in the Medical Device Industry. Our purpose is to provide unparalleled consulting services, guiding organizations towards innovation, compliance, and excellence. With unwavering dedication to safety, quality, and regulatory compliance, we empower our clients to create cutting-edge medical devices that enhance and save lives. Together, we are shaping the future of healthcare technology for a healthier world.
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 develo
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 obser
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.
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