Europe

Supporting you with complete product lifecycle solution in MDR and IVDR, we leverage our extensive knowledge of the European Medical Device Regulation and European In-Vitro Diagnostics Regulation.

Regulatory Affairs

• CE Certification Strategies
• MDR & IVDR Compliance
• CE Technical Documentation
• Regulatory Documentation
• EU Medical Device/IVD CE Marking
• European Authorized Representative (ECREP)
• Person Responsible for Regulatory Compliance (PRRC)

Quality Management

• Quality Management System
• International QMS Compliance
• Audit Management and Support

Clinical Affairs

• Uniform Clinical Solution
• Clinical Evaluation Plan (CEP)
• Clinical Evaluation under the MDR/IVDR
• Literature Review and Data Collection
• Clinical Evaluation Report (CER)
• Clinical Trial Protocol Development
• Site Selection and Management
• Patient Recruitment and Informed Consent
• Clinical Monitoring
• Data Management and Statistics
• Clinical Study Report (CSR)
• Post-Market Clinical Follow-Up (PMCF)

Post Market Surveillance

• UDI Supports
• EU Medical Device Vigilance and Incident Reporting
• Field Safety Corrective Actions (FSCA)
• Technical Documents Updates
• Periodic Safety Update Reports (PSUR)
• Notified Body Interaction and Communication