Regulatory

Quality Management System

EldonCards have been registered with the health authorities in a large number of countries, including USA, EU, Canada, India, China. The quality management system (QMS) of Eldon Biologicals A/S meets the regulatory requirements in all the markets where EldonCards are sold. Regular internal and external audits ensure compliance with the regulations at any time.

In the European Union EldonCards are classified as Annex II list A devices in the IVD directive. EC certification has been obtained in conformity with Annex V in combination with Annex VII. The QMS is certified against ISO 13485:2012 and CMDCAS.

Copies of Registration and QMS Certificates may be requested directly from our Quality Department. Lot Certificates and Certificates of Analysis are available with each delivery of products from Eldon Biologicals A/S.