Regulatory IVDR

CE-Marking compliance:

CE-marking compliance for In Vitro Diagnostic Device (IVD) manufacturers entails mainly two major steps.

1) FILES: First the Technical Documentation of the device has to be state of the art and has to comply to the responsible annex of the Regulation

2) QMS: Secondly the manufacturer has to have an effective working quality management system in order to guarantee a well controlled production. 

Both steps have to be accepted by a Notified Body before the approval and certification of the device can be received. Only after the CE-mark has been provided you are allowed to place your products on the CE markets.

FILES:

• IVDR full scope compliances; from CLass D, C , B adn Class A, Near patient tests Technical dossiers and for self-testing devices.

• Consultancy based specific according to the related MDCG, CLSI and  STED guidance.

QMS Audits:

• Regulatory compliance audit according IVDR Annex IX.

• ISO 13485:2016;.