US Region
MAVEN guides you in registering devices according to compulsory US FDA approval procedures:
- Pre-market notification 510(k)
- Pre-market approval (PMA)
- 513(g) Applications
- De Novo Petition
- Establishment Registration and Device Listing
- Medical Device Gap Analysis
- Local Agent Service
European Union
MAVEN simplifies the approval process in the EU and handles multi-lingual and complex regulatory requirements:
- Technical File Preparation and Submission
- CE Marking and Approvals
- ISO QMS Certification
- EU MDR Support
- Appointing Authorised Representative
Canada
MAVEN accelerates device approval in Canada by obtaining required licenses:
- Medical Device Establishment License (MDEL)
- Medical Device License (MDL)
