A certified quality management system

Product quality is central to everything we do.

All of our projects are overseen by a Quality Development Manager, working closely with the Project Manager and responsible for implementing all of the relevant quality tools throughout the duration of the project.

In terms of production, all of our employees are trained in Good Manufacturing Practices. We also have a quality system in place across the whole manufacturing chain, from the operators to the quality controllers and quality trainer.
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From a certification perspective, all of our products are manufactured in controlled-environment cleanrooms.

  • Ercé Médical’s management system is ISO 13485:2016 certified
  • All of the Ercé Médical oral medication delivery systems bear the CE marking, in compliance with Council Directive 93/42/EEC.
  • Ercé Médical is also a registered subcontractor with the FDA.

iso13485cefda

 

Click below to download the certificates :

Certificat_Ercé-médical-CE-93_42

Certificat-Ercé-médical-ISO-13485