www.medpace.com/device

Bring your medical device or diagnostic to market safely and efficiently with Medpace

Broad experience, global resources and local knowledge

The Medpace Difference for Medical Device and Diagnostics Studies

• Medpace physicians are fully engaged throughout the study to ensure your trials start and stay on the right path• Global regulatory experts ensure that your studies are carried out in a fully-compliant manner to meet your objectives• Robust global feasibility and site selection process• Expedited site activation and patient recruitment through a unique study management model• Real-time data review model provides accurate metrics and data efficiency• Integrated imaging, centralized ECG management, and central laboratory services deliver seamless logistics, review and testing

Experts. Experience. Execution.

Discover the POWER OF X®

Postmarket/ Postapproval

Studies

EarlyDevice

Development

PremarketClinicalStudies

Regulatory Agency

Approvals

Full Service Clinical Trial offering: • Clinical Operations • Study Start-up • Regulatory Submissions • Data Management • Biostatistics • Safety/CEC/DSMB • Medical Writing & Regulatory Affairs • Quality Assurance

Additional services offered: • Regulatory Strategy including: • Device classification • Notified body discussions • Pre-submission FDA meetings • Clinical evaluation reports, Clinical literature review (EU) • Technical files & design dossiers • EU authorized representative services

Within Medpace, a team of operations professionals is specifically dedicated to the design and conduct of clinical trials for medical devicesand diagnostic products. Our team has experience in all stages – from single-center, first-in-human and feasibility trials to multi-center,full-service pivotal trials and large-scale, post-market outcomes studies.

www.medpace.com/device

Contact InformationMedpace Medical Device - Global Medical Device HQ3787 95th Avenue NE, Suite 100Minneapolis, Minnesota 55014 USATel: +1.612.234.8500Fax: +1.612.234.8501E-mail: info.mmd@medpace.comWebsite: www.medpace.com/device

Device and Diagnostics Experience

Integrated Services Deliver Higher Efficiency

Medpace Medical Device B.V.II Fiore building B, 3rd FloorAvenue Ceramique 2276221 KX Maastricht, TheNetherlandsTel: +31 43 306 3320

Phase I Unit Central Lab

Imaging Core Lab Cardiovascular Core Lab

• Ablation Catheter• Aortic Valve• Atrial Appendage• Balloon Angioplasty• Biliary Stent• Blood Filter• CABG Stent• Cardiac Plug• Corneal Inlay• Carotid Stent• Coronary Stent• Cryogenic/Ultrasound Delivery• Diagnostics

• Diagnostic Imaging• Disc Replacement• Gastric Balloons/Staples• Gastric Stimulator• Genetic Assays• ICD/CRT-D• Implantable Cardiac Diagnostics• Insulin Delivery• Intervertebral Spacer• Intra Ocular Lens• Laboratory Developed Tests• Neurostimulator• Pacemaker

• Peripheral Atherectomy• Peripheral Stent• Point of Care Diagnostic• Retinal Imaging• Scleral Implant• Surgical Mesh• Surgical Instruments• Thrombectomy Catheter• Transcatheter Valve• Urologic Devices• Vascular Access• Ventricular Assist• Video Capsule Endoscopy