MDC Associates

About MDC Associates

MDC Associates is a contract research organization built for in vitro diagnostic (IVD) companies. The firm says it puts clinical, regulatory and quality work under one team. A diagnostic developer can take a test from study design to market submission without stitching vendors together.

Clinical studies for IVD developers

The company describes a clinical team that stands up and runs studies from planning to closeout. MDC Associates names study types including CLIA-waiver, reproducibility and usability work. Setup covers site selection, IRB and contracting, and budget planning.

During a study, MDC lists site monitoring, live data management and Trial Master File upkeep. Closeout ends with database lock and the final report.

FDA and global regulatory submissions

On the U.S. side, the firm says it prepares eSTAR 510(k), de novo and PMA submissions. It also lists breakthrough device designation, pre-submission and 513(g) requests, and U.S. representative and registration services. Strategic FDA correspondence is part of the work.

Outside the U.S., MDC names registrations with Health Canada, under the EU's IVDR and for UKCA. That work starts with strategy, gap analysis and a QMS assessment.

Quality system planning and remediation

The company describes quality work aimed at the EU IVDR transition and the FDA's move to QMSR, which aligns with ISO 13485. It lists QMS and eQMS strategy and setup, eQMS platform selection and validation, and help choosing a registrar or Notified Body. Audit support and remediation round out the service. The office is open daily from 7:00 am to 10:00 pm.

MDC says its clients are IVD makers working in infectious diseases, clinical chemistry and hematology, and point-of-care and over-the-counter testing.

In the business's own words

IVD Expertise | Medical Devices | Regulatory Affairs | CRO | Quality Systems | On-Market Support | Market Access | Market Research | Clinical KOL Network | Software Guidance | CLIA Lab Setup | Analytical Studies | Contract Manufacturing | Specimen Sourcing

From the business's own words on its Google listing, October 2026.

What this listing mentions

• Wheelchair accessible entrance
• Wheelchair accessible parking

From the business's own words on its Google listing, October 2026.