Our certificates
Certification EN ISO 13485:2012
EN ISO 13485:2012 is a certification intended for organizations that provide medical devices.
The standard puts an emphasis on regulatory requirements, custom requirements, risk management and maintaining effective processes such as safe design, manufacture and distribution of medical devices.
The certificate is published by the International Organization for Standardization (ISO) titled “Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes”.
Declaration of conformity
(according to Annex II. of Medical Device Directive 93/42/EEC and EN ISO 13485:2012)
