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Medical Device
Medpace Medical Device


Want to learn more about the Medpace difference for medical device studies? Simply fill out this form and we will contact you.


Offices

Medpace Medical Device
3787 95th Avenue
Suite 100
Blaine, MN 55014 USA
Tel: +1.612.234.8500
Fax: +1.612.234.8501

Medpace Medical Device B.V.
Maastrichterlaan 127-129
NL – 6291 EN Vaals
Tel: +31.43.306.3320
Fax: +31.43.306.3338

MMD E-mail: info.mmd@medpace.com

MEDICAL DEVICE



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  • Clinical and Regulatory Strategy

    Medpace Medical Device therapeutic, regulatory and operational leaders work closely with clients to ensure the most efficient and streamlined path to approvals nationally, regionally or globally. Attentive to our clients’ goals, operational preferences and communication needs, we customize study designs and execution strategy.

    • Clients can be confident in our study timelines because of our broad, global experience with country-specific submissions and enrollment rates
    • Regulatory affairs staff understand the challenges faced by a client when embarking on the development of new technology, can help clients understand the likely regulatory pathway and have the experience to coordinate and lead meetings with FDA or EU notified bodies
    • Geographically diverse and multilingual employees understand the local cultural environment and the regulatory pathway

    Accelerate Marketing Authorization for Medical Devices

    Medpace Medical Device leaders have the regulatory experience to leverage the fundamental differences between the regulatory processes in Europe and the United States to accelerate a medical device’s approval in both through a well-devised two-continent strategy. When planned early and in consultation with the FDA, data gathered to support a CE marking approval in Europe may be used to support an approval in the United States. More information on the two-continent strategy can be found in the article, Accelerating Marketing Authorization for Medical Devices: A Two-Continent Strategy.