Quality management / Regulatory affairs

To implement its quality policy, DeltaMed maintains a quality management system certified to DIN EN ISO 13485 for medical devices. We are certified for the design, manufacture and final inspection of medical devices in accordance with Annex II of Medical Device Directive 93/42/EEC.

Moreover, DeltaMed meets the requirements of Health Canada (CMDCAS) and the US Food and Drug Administration (FDA) for medical device manufacturers.