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To speed up your assessment, include
- Medical devices / IVD
- Product name/model + intended purpose (from IFU)
- CE status + class (if known)
- Target channel (retail/clinic/hospital/e-commerce)
- Files: IFU, label, DoC/CE certificate (if available), spec sheet
- Food supplements
- Formula with dosages per serving + serving size
- Proposed claims / positioning statements
- Current markets + target EU markets
- Files: label mockup, COA/test reports, GMP/HACCP/ISO certificates
Bucharest
Romania