Clinical studies and clinical data are more critical than ever to European Medical Device compliance. Devices that are CE marked under the new Medical Devices Regulation (MDR 2017/745) will require more post-market clinical follow-up (PMCF) studies and the clinical data presented in your Clinical Evaluation Reports (CERs) will be meticulously scrutinized.
Beyond regulatory compliance, clinical studies are an essential step in ensuring your product is safe and effective, and that it fulfills its intended use without exposing patients and users to harm. It’s important to make sure clinical studies for your device are performed in compliance with applicable standards and requirements to ensure the data is sound and acceptable to regulators. Conducting a successful, compliant clinical study is a serious undertaking that requires clinical and regulatory expertise.
Emergo is a medical device CRO specializing in European compliance
Emergo’s Contract Research Organization (CRO) in Germany is 100% focused on medical devices. Our team of experts has decades of experience conducting medical device clinical studies to European requirements. We offer a turnkey CRO solution, as we manage all aspects of post-market clinical studies – from study site selection to data analysis. Explore our CRO services:
- Medical Device Clinical Trial Study Design and Protocol Development
- GCP and ISO 14155 Compliance Consulting for Medical Device Clinical Studies
- Biostatistics for Medical Device Clinical Studies
- Medical Device Clinical Trial Management and Monitoring
- Clinical Trial Data Management for Medical Devices
- Medical Device Clinical Study Audits and Quality Control
- European Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
Comprehensive clinical and regulatory consulting for medical device companies
Once your clinical study is complete, Emergo’s CRO team can collaborate with our in-house regulatory consultants, who will package your clinical data for regulators, compile your technical file to MDR or MDD requirements, draft and update your CER, and provide vigilance support. Emergo can also act as your Authorized Representative through our office in The Hague, Netherlands.
Ready to learn more about European clinical study requirements for medical devices? Watch our free 1-hour recorded webinar presented by Dr. Jaap Laufer and Dr. Dietmar Falke, two managing members of our CRO.