Certyficates

Chema-Elektromet Spółdzielnia Pracy offers medicinal products and medical devices.

As a manufacturer of medicinal products, we apply a quality system based on the principles of GMP, which are specified in the Regulation of the Minister of Health on the requirements of Good Manufacturing Practice.

A manufacturer of medicinal products is obliged to ensure that the medicinal products they manufacture are suitable for their intended use, meet the requirements of the marketing authorization and do not expose patients to risks related to insufficient safety of use, inadequate quality or too low effectiveness. The GIF certificate is a confirmation of compliance of the manufacturing conditions with the requirements of Good Manufacturing Practice, established during the inspection.

As a manufacturer of medical devices, we use a quality management system that meets the requirements of ISO 13485 and Directive 93/42/EEC on medical devices (Medical Devices Act). By having this system, we demonstrate our ability to deliver medical devices that meet customer requirements and the requirements of the regulations applicable to medical devices.