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External assurance

As a manufacturer and supplier of medical devices, we act in accordance with a number of regulations and standards. We are compliant with the European Medical Device Directive (MDD 93/42/EEC and 2007/47/EC), as well as its counterparts in Canada and Australia. The CE marking of our products is the visual proof of our compliance to MDD. 

We also comply with the Quality Systems Regulation (21 CFR section 820), under the authority of the Food and Drug Administration, FDA in the USA. 

Wellspect HealthCare holds several management system certificates that are regularly updated as proof that we operate according to regulatory requirements. The BSI regularly conducts independent audits of our manufacturing sites and our Head Office, to verify compliance to applicable regulations and standards. 

  • ISO 13485:2016
  • ISO 14001:2015
  • MDD 93/42/EEC Annex II
  • MDD 93/42/EEC Annex V