ISO 9001 and ISO 13485
MEDALKAN is certified ISO 9001:2015 and ISO 13485:2016
ISO 9001:2015 is the standard that provides all the requirements for a system of quality management.
Thus our company responds point by point to general requirements concerning:
ISO 13485:2016 certification specifies requirements for the system of quality management when a company (company developing medical products, clinic, hospital, etc …) needs to demonstrate its ability to provide medical devices and related services regularly and compliant to the requirements of the customers and the regulatory requirements relevant to medical devices and related services.
Thus, Medalkan meets the particular requirements for medical devices such as:
- Compliance with regulatory requirements;
- The control of special processes;
- The risk analysis throughout the product development;
- Clinical trials and the long-term monitoring of these trials;
- Traceability of products from conception to commercialization
This certification is a proof of commitment from Medalkan concerning the quality of its products and enables it to demonstrate that its system of quality management has been assessed and found compliant with regulatory requirements and customer needs.
MEDALKAN’s full range of products are labeled CE
The CE marking indicates the compliance with EU legislation of a product, wherever in the world manufactured, and enables its free movement within the European market.
The products for the cleaning and disinfection for the medical area must meet the requirements of the European Directive 93/42 / EEC on medical devices imperatively before being placed on the market.
The disinfectants for medical use, considered as medical devices, therefore respond to the requirements of this directive. The CE marking on the label of a cleaning disinfectant for medical use is possible only if all the criteria of Directive 93/42 / EEC are respected.