After decades of attendance, MDC Associates will be exhibiting for the first time at ADLM 2024 in Chicago, booth #5345.
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MDC Associates, a leading full-service firm, specializes in guiding in vitro diagnostics (IVDs) and medical devices through the rigorous regulatory, quality, and clinical requirements for market approval. During its over 35 years of industry experience, MDC Associates has supported many clients, from innovative startups to large international organizations. MDC’s extensive expertise spans various fields, including microbiology, infectious diseases, clinical chemistry, and companion diagnostics. After decades of attendance, MDC Associates will be exhibiting for the first time at ADLM 2024 in Chicago, booth #5345.
MDC Associates’ mission is to provide in vitro diagnostic innovators with exceptional support and personalized solutions to make the world healthier. Over its distinguished history, MDC has supported over 700 IVD and MedTech clients, conducted over 100 clinical studies in the US and EU, and managed over 140 FDA submissions. Notably, the company has achieved several Breakthrough Device Designations in the past two years and handles approximately 20 FDA Q-submissions annually. Headquartered in Boston, MDC Associates maintains a strong presence with US and European consultants.
In regulatory affairs, MDC develops robust strategies, performs comprehensive gap analyses, and manages all regulatory submissions, including 510(k), De Novo, PMA, Health Canada, and CE/IVDR. The firm supports FDA registration and listing, provides US agent representation, conducts regulatory due diligence, and manages quality audits to ensure compliance and market readiness.
MDC Associates excels in implementing and maintaining quality management systems (QMS/eQMS) that comply with IVDR and ISO standards. The company prepares for and manages audits, manages complaints, oversees Corrective and Preventive Actions (CAPA), advises on remediation actions, and handles product recalls precisely and efficiently. MDC's commitment to quality systems ensures its clients meet the highest regulatory compliance standards.
As a premier CRO, MDC Associates designs and develops clinical, analytical, and usability study protocols tailored to each client's needs. The firm identifies and qualifies study sites, manages contracts, handles Institutional Review Board (IRB) management, and oversees comprehensive study management. This includes data management, analysis, visualization, and the preparation of detailed study reports. MDC ensures meticulous management of trial master files and data transfers, assuring clients of accurate and reliable clinical study outcomes.
MDC Associates' industry experience spans over three decades, supporting a diverse client base from small startups to large international organizations. The company’s technical expertise includes microbiology, infectious diseases, clinical chemistry, and companion diagnostics. With an impressive track record of over 140 FDA submissions and handling more than 520 FDA Q-subs per year, MDC is a trusted partner for regulatory submissions. The firm has conducted over 100 clinical studies in the US and EU, providing unparalleled support to over 700 IVD and MedTech clients.
The firm’s expertise extends to various device types and applications, including CLIA Waiver/Home Use Devices, Molecular Diagnostics (Direct/PCR/Microarrays), Antigen/Antibody Tests, Mass Spectrometry (MALDI), Antimicrobial Susceptibility Testing, Digital Imaging & Analysis, Next-Generation Sequencing, and Sample Collection Devices. MDC's applications include Microbiology, Infectious Diseases, Clinical Chemistry, Hematology, Women’s Health, Diabetes, Oncology, Genetic Testing, and Companion Diagnostics.
MDC Associates develops comprehensive regulatory submission strategies, defining intended use, identifying applicable regulatory pathways, managing risks, and considering pre-submission interactions. The firm prepares detailed submission packages and manages the entire process from study design to FDA application and approval.
For more information, please visit MDC Associates' website at http://mdcassoc.com. With a headquarters in Boston and consultants across the US and Europe, MDC Associates stands ready to support IVD and MedTech innovators in navigating the complex regulatory landscape and achieving market success.
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 30 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. 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 the company: 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: 89137114
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