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MDC Associates
Beverly, Massachusetts, United Statesmdcassoc.com ↗
- Ownership
- Private
- Employees
- ~93
- Development stage
- Commercial
01
Overview
MDC Associates provides regulatory, quality systems, and clinical research services to companies developing in vitro diagnostic (IVD) products and medical devices. They guide clients through study design, regulatory submissions (including FDA Pre-subs, 510(k), De Novo, PMA), quality system implementation (ISO/MDSAP), and data management for clinical trials. Their expertise spans microbiology, infectious disease diagnostics, oncology assays, diabetes monitoring tools, genetic tests/CDx products and more. No proprietary clinical results as they are a CRO/service provider.
- Therapeutic areas
- OncologyInfectious DiseasesEndocrinologyHematologyOtherWomen's Health
- Modalities
- DeviceDiagnostic technologyData management solutions (for clinical studies)
- Industry
- Contract Research Organization
02
Partnerships
Extensive partnerships with IVD manufacturers/startups/growth-stage companies seeking regulatory or clinical support.
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