SPECTRUM OF SERVICES
- Registration of medical devices and medicines
- Complex questions of appeal, answers to complaints
- Consulting in the field of registration of medical devices
Registration of medical devices of all risk classes and types, including equipment and devices for in vitro diagnostics:
- formation of the list of registration dossier for the product.
- assistance in the preparation / revision of documents.
- accompaniment of toxicological, clinical,
technical and clinical laboratory tests of a medical device.
- submission of documents for registration and record keeping.
- assistance in the registration process on any questions that have arisen at any stage of registration.
Elimination of violations identified by Roszdravnadzor in the process of monitoring the circulation of medical devices:
- preparation of all necessary documents, full support of the case until a positive conclusion of the RZN is received.
- Registration of medical devices and medicines abroad.
- Conclusion honey. products and medicines to the Russian and foreign markets for its commercialization.
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