Estimation of medical products’ compliance

New legislative regulations that came into effect from 2015, concerning the system of medical products circulation at the Ukrainian market, have cardinally changed order and content of regulatory procedures.
The procedure of compliance estimation with Technical regulations, adopted by the regulations of Cabinet of Ministers of Ukraine №№ 753, 754, 755 dated 02.10.2013, changed classical registration of medical products.
Such estimation is carried out by the appointed body on compliance estimation; the procedure depends on the type of medical product.
We are ready to render comprehensive assistance with the procedure and its further maintenance at all stages, if necessary.

The company 8L GROUP offers the following types of services and accompanying decisions on medical products:

Estimation of compliance with Technical regulations

Assistance in the procedure of self-avowal

Estimation of medical products’ compliance

Estimation of compliance with Technical regulations

Assistance in the procedure of self-avowal

Preparation of technical documentation package to present in the authorized body on compliance estimation

Maintenance of audit bodies on compliance estimation

Development and maintenance of SMK (ISO 13485, ISO 9001) implementation

Development of technical documentation, maintenance of the system implementation at the enterprise

Maintenance of audit bodies on compliance estimation

Development of Technical conditions

Development of Technical conditions for medical products