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Certificates

Mediracer Ltd’s quality system has been designed and certified according to the ISO 13485:2003 standard. Processes are clearly described and instructions are proportioned to the size of the company and the scale of its operations to ensure compliance with official regulations. Development of the quality system is also a key element in the company’s growth and development. Mediracer Ltd uses only suppliers that have a properly certified quality system.

Certificates:

EC-certificate, Medical Device Directive 93/42/EEC, VTT Expert Services Ltd (Notified Body No. 0537).
Certificate No. VTT-C-6602-01-1102-430-11

Quality system certificate, ISO 13485:2003, VTT Expert Services Ltd.
Certificate No. VTT-C-8386-60-12