We assist companies to register their devices in all countries:
- USA (510(k))
- Canada
- Europe (CE Mark under MDR/IVDR)
We also assist companies to register their devices in Latin America, Asia Pacific countries:
- Australia
- Brazil
- Canada
- China
- Costa Rica
- Hong Kong
- India
- Japan
- Malaysia
- Mexico
- Singapore
- South Korea
- Taiwan
We can do the gap analysis for a harmonised switch from directives to regulations in terms of classification, labelling, post-market surveillance, economic operators. We can help you to create, review the technical documentation. We can communicate with the notified body or competent authority on your behalf.