Regulatory Affairs
CE Marking (MDR 2017/745 & IVDR 2017/746)
We assist you in preparing complete technical documentation, ensuring conformity with European regulations, and obtaining CE marking efficiently.
- Technical Documentation & Design Dossiers
- Risk Management (ISO 14971)
- Usability (IEC 62366-1)
- Software compliance (IEC 62304)
- UDI & Post-Market activities
FDA Registration
Comprehensive support for U.S. market access, including QMS setup and submissions to the FDA.
- 510(k), PMA, De Novo submissions
- QMS compliance to 21 CFR 820
- Establishment Registration
- Labeling & UDI requirements
Global Market
International Registration & Representation
Your trusted partner for device registration across Africa, the Middle East, and other regions.
Local Representation (Authorized Representative)
mportation & Distribution Support
Market Access Strategy
