We are FDA registered and are also ISO-certified according to SS-EN ISO 13485:2016 The company is also carrying the EC certificate – Production Quality Assurance System Approval Certificate according to Annex V of the Directive 93/42/EEC on Medical Devices.
Care for the environment is one of the key issues when we select production methods and material. Our quality policy assures full traceability of material and labour in every production step from raw material to finished products.
Download pdf for our - CE Certificate
Download pdf for our - SS-EN ISO 13485:2016 Certificate