EU MDR & IVDR Consulting
BioReg can help you obtain EU MDR or IVDR CE Marking for your medical device. Our services, among others, include:
- Medical device classification
- Verification of applicable standards and testing requirements
- Writing MDR or IVDR Technical Documentation or review
- Review of Labeling & UDI
- Verification of compliance with General Safety and Performance Requirements (GSPR)
- Writing Post Market Surveillance (PMS) Plan & Reports (including PDUR)
- Writing Post Market Clinical Follow-up (PMCF) Plan & Report
- Writing Literature Search Plan (Protocol) & Report
- Writing Clinical Evaluation Plan & Report
- EUDAMED Actors and Products registration
- Building and maintenance of a Quality Management system (ISO 13485)
- Risk assessment and management (ISO 14971:2019) Plan & Report
- Development of Risk, Clinical Evaluation, Vigilance, and PMS procedures
- Evaluation of significant changes
- Devices without a medical purpose
CONTACT US
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.
