"Yes, we've got a great track record for gaining marketing clearance for medical devices. We're on top of the constantly changing regulatory requirements, so guiding you through the FDA Premarket process is an easy one for us."

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MDCI provides a full range of regulatory assistance and support to medical device companies. We can help you develop and implement the most advantageous regulatory strategy for your medical device, and prepare and submit the necessary documents to regulatory agencies to obtain marketing clearance.

Our consultants have extensive product experience and skills in regulatory affairs and an in-depth understanding of FDA, Canadian, and European requirements for marketing medical devices. MDCI consultants include former senior regulatory affairs personnel from industry, as well as former senior FDA officials who were responsible for the review and approval of new medical devices.

With the combined experience and technical skills of our consultants, we can assist both large and small companies in bringing their products to market in the most direct, cost-effective manner. We can handle single projects, supplement your existing staff for specific tasks, or provide complete regulatory support for your company.

KEY REGULATORY SERVICES

Developing and Implementing Regulatory Strategies

Assess impact of regulatory environment and FDA policies

Design pre-clinical and clinical studies

Evaluate technical and clinical data

Communicate and meet with FDA

Preparing and Submitting Regulatory Documents

Investigational Device Exemption (IDE) applications

Pre-market notifications [510(k)s]

Pre-market approval (PMA) applications

Device reclassification petitions

Master files

Canadian device license applications

Technical files for EU marketing

Reviewing and Developing Instruction Manuals and Other Labeling for FDA Compliance

Providing Liaison with FDA

U.S. Agent Services

Temporary On-Site Regulatory Staffing and Support

European Regulatory Consulting

CE Mark Consulting Services

European In Vitro Diagnostic (IVD) Directive

European Authorized Representative