a. Preparing complete CE technical files for self-certified IVD devices to market in European countries.
2. Self-Testing/OTC CE Marking
a. Submission and Obtaining Self-Testing (OTC) CE certificate for IVD devices to market in European countries.
3. High-Risk CE Marking
a. Submission and obtaining High Risk (Device A and B listed in EC Directives) CE mark for IVD devices to market in European countries.
4. Updating CE Marking Annual Files
a. Updating technical files for IVD devices to renew annual CE marked products.
5. EU-MDR, EU-IVDD, IVDR
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