Our service covers all CE certification activities, including:
- CE MDR Review & Gap Analysis
- MDD-MDR transition
- Initial MDR CE certification
- CE marking for Class I manufacturers
- Pre-review of Technical Files
- Writing of Clinical Evaluation, Literature and PMS-PMCF plan & report
- CE audit management
- PRRC (Person Responsible for Regulatory Compliance) service
- Liaison with regulatory parties (Notified bodies, Authorized Representatives, Competent Authorities) and
- EU-MDR auditing & training
For more information, please contact the BioReg team.
CONTACT US
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.
