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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: firstname.lastname@example.org
Fact Sheet: MMD Overview
Fact Sheet: Cardiovascular
Fact Sheet: Ophthalmic
Fact Sheet: Orthopedic
Strategic and Hands-On Medical Device Expertise
Clinical and Operational
Medpace Medical Device is managed by a team with extensive device industry experience, from large companies to small start-ups, giving us unique insight into a client’s company culture and the ability to be responsive to your needs.
Medpace has a unique physician-managed approach to studies. Our full-time staff physicians are fully engaged throughout the entire study. They provide strategic direction for study design and planning, train operational staff, work with primary investigators, provide medical monitoring, and meet with regulatory agencies.
Our medical device project managers average more than 10 years of medical device clinical trial experience and their average tenure at Medpace is seven years. Our project managers are able to ensure consistent, stable and reliable execution across all studies.
Regulatory Affairs Expertise
Regulatory leadership at Medpace Medical Device is provided by a senior director of regulatory affairs who has more than twenty-five years of executive-level experience in global medical device regulatory affairs, regulatory compliance, quality assurance and clinical research, with particular emphasis on cardiovascular and peripheral vascular technologies.
The medical device regulatory team:
- Includes staff with significant global regulatory experience—each of our regulatory consultants have more than 10 years of direct responsibility with premarket regulatory submissions and negotiations with regulatory agencies
- Has extensive experience in developing global regulatory strategies for complex devices including preclinical and clinical data requirements—including Class I through III products, combination products and drug delivery devices
- Coordinates and leads meetings with regulatory agencies on a frequent basis, understands the current regulatory climate and can provide consultation that addresses current regulatory issues
- Develops quality systems compliant with medical device requirements and manages certification process
- Augments your quality system by conducting internal audits or participates in risk management process
- Provides regulatory consulting services and supports the development of documents related to pre-IDE, IDE, PMA, 510(k) and CE marking applications
- Conducts formal literature reviews to support regulatory submissions or demonstrate conformity for CE marking
- Can serve as your European authorized representative through our device headquarters in Europe