Certification

ExpressCert Program

Getting your Medical Device to market quickly without sacrificing quality is critical. Inefficiencies in the process can slow down your device’s market access.

Need to Get your Medical Devices into Europe Fast? Choose our ExpressCert Program!

You need a Certification Body that is an Expert at both efficiency and your device, one that will help you protect your investment.
GMED is able to perform CE Marking assessment in accordance with all applicable European Medical Device Directives:

A Faster Standard Review Time

GMED’s Expertise in efficiency means that our standard assessment time is in line with the needs of the industry.

Assessment for:30 Working days
Quality system according to the provisions of the European directives (CE Marking)From the last day of the on-site Audit
The Medical Device according to the Essential requirements of the CE Marking (Design Dossier - Technical Documentation)As soon as we receive your Design Dossier/Technical Documentation
A Faster Standard Review Time

Express Certification Program

Need to Get your Medical Devices into Europe Fast? Choose our ExpressCert Program!

A Faster Standard Review Time

Express Certification Program

Need to Get your Medical Devices into Europe Fast? Choose our ExpressCert Program!

gmed assist

Can GMED Really
Assess My Device in 30
working days?

Through the ExpressCert Program, GMED wiil coordinate and ensure that resources are available to devote time to the review of your device. Before getting started, we will perform a preliminary review to determine if we need any more information. The clock starts as soon as we receive the last piece of information needed from you or at the end of the audit! As long as there are no major issues or non-conformities, within those 30 working days, you will receive the opinion of our committee.*

* Our ability to accommodate ExpressCert certification depends on your capacity and on how quickly you can provide us with the required information needed to assess the regulatory compliance of your device. Note that a positive outcome of our assessments (issuance of a certificate) within 30 working days cannot be guaranteed.
** Please note that the ExpressCert service does not guarantee a positive result of our assessments (issuance of a certificate) within 30 working days and doesn’t modify or accelerate the duration of our evaluations (such as audit duration or the time required to assess the conformity of the product).

Certification News

Library of regulatory updates, certification information, and other updates in the medical device field.

Plan commun de mise en œuvre et de préparation pour le...

L’objectif de ce document est d’identifier les actions prioritaires à mettre en place en vue de répondre aux exigences du (...)

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Save the date : Forum – Logiciels de DM | 28...

Le 28 septembre prochain, GMED organise le Forum – Logiciels de DM : quelles exigences applicables en vue de leur mise (...)

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Questions & Réponses de la Commission européenne sur la nomenclature européenne...

La Commission européenne vient de publier un document regroupant des questions et réponses sur l’EMDN. Conformément à l’article 26 du (...)

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FAQ sur la nomenclature européenne des dispositifs médicaux (EMDN)

Le Groupe de Coordination en matière de Dispositifs Médicaux vient de publier la FAQ MDCG 2021-12 sur les dispositifs médicaux (...)

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Version anglaise de la nomenclature européenne des dispositifs médicaux (EMDN)

Une consultation publique a été organisée par la Commission européenne sur la nomenclature européenne des DM et DM DIV (EMDN) (...)

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Guide MDCG 2021-08 sur les documents de demande et de notification...

Le Groupe de Coordination en matière de Dispositifs Médicaux (GCDM) vient de publier un guide sur les documents de demande (...)

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Fiche d’information de la commission européenne pour les fabricants de dispositifs...

Vous êtes fabricants de dispositifs médicaux implantables ? Tout ce que vous devez savoir sur la carte d’implant et les (...)

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Règlement (UE) 2017/746 : Introduction

Le Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro (RDIV) est entré en vigueur le 26 mai 2017 (...)

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Actualités

Accèdez à toute l’information technique, réglementaire et normative sous forme de guides, webinars, news…

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Upcoming Training

CE Mark Training First Session [Sample]

2- Day Training for RA/QA Professionals of the MD Industry: The Regulation (EU) 2017/746 for IVD Devices

Contact Us

To find out more about our ExpressCert Program