Need to Get your Medical Devices into Europe Fast? Choose our 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, causing you to lose market share and your bottom line.
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:
- 93/42/EEC – Medical Devices (including combination products incorporating a medicinal substance or an Animal Origin Substances)
- 90/385/EEC – Active Implantable Medical devices
- 98/79/EC – In Vitro Diagnostic Medical Devices
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|
Can GMED Really Assess My Device in 30 working days?
Through the ExpressCert Program, GMED is responsible to 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.*, **
To find out more about our ExpressCert Program, Contact us.
* 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).