Our company has been accredited for certification according to ISO 13485:2016
Manufacture of medical devices is a special industrial branch, since these devices and equipments are used in medicine, so the safety of them has an enhanced importance in addition to the intended use.
Standard ISO 13485:2016 rules the procedures of manufacture of medical devices from the design to the application. It guarantees that the product fulfils the regulatory requirements of Hungary and the European Union.
Standard ISO 13485:2016 has been prepared for such organisations that, for using the CE mark on their products, shall conform one or more “New Approach” European directives on medical devices.
A certified ISO 13485 quality management system provides the following added values:
During the validity of the certificate, an external and independent certification organization proves that your procedures fulfil the requirements of the standard.
You’re entitled to use our certification mark
You can get a priority in public procurements
Quality management system certification of manufacturers and service providers of medical devices according to standard ISO 13485
Information on the certification procedure
Certification procedure of CE Certiso Ltd is shown by the following diagrams:
Initial conformity assessment procedure
Surveillance conformity assessment procedure
Renewal conformity assessment procedure