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Medpace Medical Device
3787 95th Avenue
Blaine, MN 55014 USA
Medpace Medical Device B.V.
NL – 6291 EN Vaals
MMD E-mail: email@example.com
Fact Sheet: MMD Overview
Fact Sheet: Cardiovascular
Fact Sheet: Ophthalmic
Fact Sheet: Orthopedic
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.