ISO 13485 Quality Management System.

Ensure secure certification of your products from start to finish.


Make sure your medical devices meet global requirements.


Increase the effectiveness and patient safety of your products.


Accelerate time-to-market and successful product launches.

What you should know about ISO 13485 quality management systems.

With hardly any other product does quality have such a direct impact on the efficacy and safety of patients, users and possibly others as with medical devices.

Therefore, many national regulations require manufacturers and suppliers of medical devices to prove that they have a quality management system in place. This quality management system is audited and certified by an independent body.

If manufacturers or suppliers do not have a certified quality management system, it is usually more difficult for their products to be approved in the large, important markets. Delays in market entry and loss of sales can be the result.

Why ISO 13485 certification is important.

In the European Union, the requirements of EN ISO 13485 have been harmonised with the requirements of the EU Medical Devices Directive (93/42/EEC), the In Vitro Diagnostic Medical Devices Directive (98/79/EC) and the Active Implantable Medical Devices Directive (90/385/EEC).

Certification according to EN ISO 13485 by an accredited certification body automatically leads to a presumption of conformity. Accordingly, a manufacturer certified to EN ISO 13485 is presumed to comply with the aspects of the requirements of these directives covered by the standard.

The advantages of ISO 13485 at a glance.


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Case Studies.

ISO 13385 certification for an IVD products start-up.

A start-up founded six months ago is developing an IVD product and wants to be certified for DIN EN ISO 13485.


  • Suitable notified body selected
  • Processes established and put on paper
  • Employees trained on new QMS
  • Accompanied by internal CAPA audit and first audit
  • Sustainable quality culture established that guarantees successful audits in the future

The customer from the medical technology sector had many deviations in the last audit and therefore saw a short-term need to update its quality management system together with Entourage in order to successfully complete the follow-up audit.


  • Existing problems analysed and eliminated
  • Processes jointly optimised and implemented in the respective departments
  • Successfully accompanied through the next audit

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