Your Partner at Every Stage

Partner for Startup Companies Bringing innovation to market can be daunting for a relatively new company. It's important to choose the right partner when gearing up for that next phase. The MDC team is an experienced and collaborative CRO available to accelerate your path to market approval.

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CLINICAL SERVICES

Our full-service team of clinical scientists, site managers and data analysts are ready to execute. We have extensive experience managing a broad range of in vitro diagnostics studies.

REGULATORY SERVICES

Our experts can guide you from strategy through submission for U.S. FDA market authorization and beyond.

QUALITY SERVICES

We’ll get your team ready to bring your medical device into compliance. Let us help you develop a quality assurance strategy, select and validate a QMS/eQMS platform, and get your team prepared for QMS and FDA inspections.

Partner for Growth Companies You're on-market with your first platform - Congratulations! It's time to take those next steps, whether it is post-market requirements, technical documentation maintenance, or preparing for the next product's market access.

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CLINICAL SERVICES

In this stage of growth, the need for a comprehensive in-house clinical team can be difficult to justify. It often makes good sense to partner with a CRO for just-in-time clinical services. Our full-service clinical research team of scientists, clinical operations and data management can plug-in when needed.

REGULATORY SERVICES

You’re ready to expand claims, remove limitations, and extend menu on the existing platform. MDC is at your service.

QUALITY SERVICES

Let our quality assurance team help with ongoing quality system support. From internal quality audits, CAPA / complaint management, and FDA inspection preparation, our experts are on call.

Partner for Established Companies You're a mature medical device firm with multiple products on-market and an in-house team that can handle the day-to-day operations. That said, there are periods when the team is stretched thin or outside expert counsel is needed to meet business objectives.

reaching the top of the mountain

CLINICAL SERVICES

Clinical studies are a massive lift for any size organization, often leveraging the same team members responsible for keeping existing products on-market and compliant. MDC’s full-service team of scientists, operations and data management can act as an extension of your team to expedite bringing new products to market.

REGULATORY SERVICES

Whether the company is assessing a new market or your current team lacks bandwidth, MDC’s broad IVD expertise can be leveraged to quickly get the job done.

QUALITY SERVICES

Let our quality assurance team help with ongoing quality system support. From internal quality audits, CAPA / complaint management, and FDA inspection preparation, our experts are on call.

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