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