Medeco is certified!
Our quality manual has been audited, our staff have been questioned and our processes have been scrutinized. Medeco was recently the subject of a thorough internal audit. We passed with flying colours and are now DS/EN ISO 13485:2003 and KEMA 93/42/EEC certified.
But what do these certificates entail?
The ISO-13485 certificate is awarded for processes applied by the marketing, sales and logistics departments that relate to the supply of products and services in the health-care sector. It assesses whether our organization is able to meet client-specific demands and statutory and regulatory requirements and Medeco's own internal constraints.
Medeco's own brands
Our own brands must comply with the 'Medical Devices Directive (93/42/EEC)'. KEMA is our 'Notified Body'. KEMA carries out a conformity assessment every year to evaluate whether both our processes and our products consistently comply with the relevant requirements. This safeguards the continuity and quality of supply of our products and services.