Le service Qualité - Affaires réglementaires et Matériovigilance, certification NF EN ISO 13485 - Société Cereplas

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— News updates —

Carta de información

Following the prohibition of some breast implants , you'll find more information about the CEREFORM® implants

by clicking here

EUROMI and CEREPLAS are merging

EUROMI and CEREPLAS are glad to announce their merger into a same economic entity. This new group will propose to all our customers a product range that will be even more complete and innovative.

The Company — Quality —

> Quality, Regulatory Affairs and Materio-vigilance Department*

  • Ensuring gathering and analysis of datas coming from our clients;
  • Monitoring the set-up and application of Quality System Management;
  • Monitoring the application of the European and French regulations in force during design, production and distribution of products;
  • Ensuring management of quality controls carried out throughout the products manufacturing;
  • Setting up validation procedures for equipment, processes and infrastructures involved in the products manufacturing.

> NF EN ISO 13485 certification :
An essential stage in obtaining the EC label for long term implantable medical devices

The diversification to long term implantable medical devices undertaken by CEREPLAS had to be certified to industrial standard NF EN ISO 13485: 2012, CEREPLAS obtained this certification in February 2006.

This allowed us to set up an effective quality management system with a view to obtain the EC label for our devices in accordance with European directive 93/42/EEC.

A EC label is never obtained definitively. A follow-up audit must be carried out every year and a renewal audit carried out every three years. These audits are carried out by an independent auditor, appointed by our notified body, LNE/G-Med (national trials laboratories).

The objective of these audits is to test and verify the quality management system and medical devices we produce in accordance with the regulatory, technical and normative requirements. Those audits are essential to guarantee the medical devices manufactured by CEREPLAS quality,

LNE CE

Télécharger les certificats LNE Gmed

  • Glossary

  • materio-vigilance : monitoring problems relating to medical devices