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MDC Associates is streamlining the path to achieving Clinical Laboratory Improvement Amendments (CLIA) Waiver certification, marking a milestone for companies bringing diagnostic solutions to market. MDC Associates is helping companies navigate the complexities of obtaining a CLIA Waiver efficiently and confidently through support, strategic planning, and specialized regulatory expertise. With over 35 years of experience guiding in vitro diagnostics (IVDs) and medical devices through intricate regulatory landscapes, MDC Associates is positioning itself as a leading consultant in diagnostic device compliance.
MDC Associates, with its proven track record of supporting over 700 IVD and MedTech clients globally, is a proven partner in navigating the path to CLIA Waiver certification and beyond. The company’s team of seasoned experts has developed streamlined approaches that allow clients to efficiently handle regulatory documentation, quality audits, and clinical study design, all while prioritizing safety and compliance with FDA requirements.
A CLIA Waiver certification opens doors for diagnostic devices to be used in decentralized healthcare settings, where rapid, accurate testing is critical. By working with clients to craft a regulatory pathway, MDC ensures that companies can secure the necessary approvals and certifications to deliver their technologies to diverse settings. The firm has developed a unique, personalized approach that includes strategic guidance tailored to each device’s intended use, which helps identify the best possible pathway for regulatory approval. This means a faster, more efficient process focusing on the client’s specific market goals.
The path to CLIA Waiver approval includes several layers of review, rigorous testing, and extensive documentation. MDC Associates leads clients through this process by crafting detailed study protocols and managing institutional review boards (IRB) to ensure that every clinical and usability study meets stringent regulatory standards. MDC’s clinical research organization (CRO) services extend to identifying and qualifying study sites, monitoring studies, and managing all aspects of clinical trials. From handling trial master files to managing study logistics and data transfers, MDC’s team is fully equipped to support high and moderate-complexity laboratory tests and point-of-care and at-home tests, which are key components of CLIA Waiver applications.
While CLIA Waiver certification is a major focus, MDC Associates offers a wide range of regulatory services for IVD and MedTech clients. In addition to the regulatory strategies for the US, the firm also supports clients aiming to expand globally. MDC is known for its expertise in handling international regulatory submissions, including those required by Health Canada and under CE/IVDR guidelines in Europe. MDC’s extensive experience with FDA Breakthrough Device Designation and over 140 successful FDA submissions demonstrates its commitment to advancing diagnostic innovation internationally.
MDC’s broad experience spans multiple therapeutic areas, including microbiology, infectious diseases, clinical chemistry, oncology, and genetic testing. This expertise equips the firm to guide clients in areas requiring specialized knowledge. As healthcare continues to evolve toward decentralized and accessible diagnostics, MDC’s role in facilitating the path to CLIA Waiver certification becomes increasingly important. MDC Associates supports the global healthcare community in pursuing timely and effective patient care solutions by driving innovation and reducing barriers to market entry.
Through its unwavering commitment to regulatory excellence and quality, MDC Associates is not only helping diagnostics companies meet today’s rigorous standards but also setting the stage for the future of patient-centric diagnostic solutions. As more diagnostic devices become accessible to a broader range of healthcare settings, MDC continues to lead the way, simplifying the path to CLIA Waiver certification and empowering medical device innovators to make a meaningful impact on global health.
About MDC Associates:
MDC provides life-saving diagnostic makers with the right support and catered solutions needed to make our world a healthier place. With over 35 years of experience, MDC Associates has the experience and expertise to provide unparalleled regulatory strategy and execution, full-service CRO planning and study management, quality systems design and implementation, and data management support, guidance, and analysis. Located on the technology corridor north of Boston, Massachusetts, MDC has earned a reputation of trust with companies of all sizes that develop, manufacture, and distribute in vitro diagnostic tests and instruments. The unique way MDC focuses its work and counsel guides clients in demonstrating safety and efficacy to achieve product approval, making MDC a valuable partner on the path to commercial success.
About Us: MDC provides life-saving diagnostic makers with the right support and catered solutions needed to make our world a healthier place.
Contact Info:
Name: Kevin Roy
Email: Send Email
Organization: GreenBanana
Website: http://www.greenbananaseo.com
Release ID: 89144677
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