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Certifications:

EN ISO 13485:2012  Medical Devices - Quality management Systems - Requirements for regulatory purposes

ISO 13485:2003 CMDCAS (Canadian Medical Devices Regulations - SOR/98-282)

EN ISO 14001:2004  Environmental management systems - Requirements with guidance for use 

Compliance according to:

FDA 21 CFR 820  Quality System Regulation - Medical Device Good Manufacturing Practices

Medical Device Directive 93/42/EEC

Japan Quality Management System Compliance - MHLW Ordinance No. 169


Medicom services  

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