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Quality Management Consultancy

Medical Devices

Our experts will help you to create and operate an efficient quality management system that minimises overheads and complexity. Advena’s services include support for ISO 13485 and the ACTIV online management system.

We can help with the preparation, installation and auditing of electronic or paper quality management systems to:

  • ISO 13485
  • ISO 9001
  • EU Medical Device Directive 93/42 EEC Quality Requirements in Annex II and V
  • IVDD
  • GMP ISO 22716
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