GloriMed Consulting : conseil, expertise et stratégie, pour un accès personnalisé au marché des dispositifs médicaux.
MARKET POSITIONING - CE MARKING
MISE SUR LE MARCHE

To be available on the market, a medical device needs to be correctly CE marked  and this is the manufacturer's responsibility.
To enable the use of CE Marking on a medical device, the manufacturer must submit its product to a conformity assessment procedure with the essential safety and performance requirements described in the applicable European directives.

The conformity assessment may require working with a government approved testing facility. (Monitoring and Market surveillance are conducted by the competent authorities of the member states).

GloriMed Consulting will support you and assist you in obtaining and maintaining the CE Marking of your medical device.

Our services:  
Development of the certification strategy
Analysis of the product concerned: audit confirming that the product is a medical device, identification of the corresponding class.
Determination of the guidelines to be followed.
Identification of the procedure of certification best suited to obtain the CE Marking.
Follow-up of the design file of the product.
Continuous improvement of the action plan, according to standards and regulations.

Conformity assessment of the medical devices
Communication coordination with the relevant authorities and notified bodies (declaration procedures, communications).
Preparation of the technical file for the CE Marking:
- collection and compilation of the available elements,
- coordination of the tests conducted by independent accredited testing laboratories,
- critical analysis of the existing scientific literature,
- translation coordination.

Materiovigilance

Compliance of the files for the CE Marking of the medical device
Regulatory and standards monitoring.
Adjustment of the CE conformity Marking.

Present us with your projects, we will work together to fulfill your needs.
Contact us by e-mail at: export@glorimed.fr or via our Contact form.

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