Certificates

At Control-X, quality and compliance are paramount. We hold major medical certificates to comply with requirements on different markets. Our Quality Management System and products are audited by SGS Hungary.

Cetrificate		Download Copy
Quality Management System		ISO 9001:2000
Medical QMS Certificate		ISO 13485:2003
European Directive (Medical CE)		Medical Directive
FDA Approval		FDA Certificate
CE Mark for Veterinary Products

Medical systems and individual components are CE certified. Our products comply with the following standards and regulations (as applicable):

• EU Medical Device Directive 93-42-EEC
• EN ISO 60601-1: Medical Electrical Equipment - General safety requirements
• EN ISO 60601-1-1: Safety requirements
• EN ISO 60601-1-2: Electromagnetic compatibility
• EN ISO 60601-1-3: General requirements for radiation protection in diagnostic X-ray equipment 
• EN ISO 60601-1-4: Programmable electrical medical systems
• EN ISO 60601-2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
• EN ISO 60601-2-32: Particular requirements for the safety of associated equipment of X-ray equipment
• EN ISO 14971 Application of risk management to medical devices
• EN55011 Electromagnetic disturbance characteristics