Certifications:

EN ISO 13485:2003  Medical Devices - Quality management Systems - Requirements for regulatory purposes

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

Compliant to:

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

Japan Quality Management System Compliance - MHLW Ordinance No. 69

Canadian Medical Devices Regulations - SOR/98-282

Implemented standards:

EN 60601-1:2006  Medical electrical equipment - General requirements for basic safety and essential performance      

EN ISO 14971:2009  Medical devices - Application of Risk Management to medical devices

EN 62366:2008  Medical devices – Application of Usability Engineering to medical devices

EN 62304:2006  Medical device software – Software lifecycle processes