Medical Devices: ISO 13485

The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market.

ISO 13485: 2003 has been harmonised against the three Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices) so certification to this standard by an accredited certification body such as TÃœV SÃœD automatically demonstrates compliance with specific clauses in the regulations.

Benefits of ISO 13485:

  • Formal certification, specifically for medical devices to ISO 13485: 2003 helps market products and services.
  • Operating costs drop as rework is reduced and efficiencies increase

Your advantages:

  • ISO 13485 certification from TÜV SÜD is one of the most recognised and respected in the global medical device market.
  • We focus on the effectiveness of the system and the practicality to the local environment.
  • We ensure added value by focussing on the intent and usefulness of a quality system.