Assessment of compliance of medical devices and equipment with requirements of technical regulations
- Counsel on the preparation of declaration of conformity (with annexes) of technical regulations;
- Counsel on the compliance of technical documentation of the manufacturer of medical devices with requirements of the Ukrainian legislation;
- Assistance in the preparation and development of technical documentation;
- Support during the audit of production facilities for compliance with production quality management systems;
- Preparation of documents for audit by the State Administration on Medical Products and Drug Control.
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