 Need to Get your Medical Devices into Europe and Canada Fast? Take the Express Lane with G-MED North America’s ExpressCert!
G-MED North America is the North American subsidiary of LNE/G-MED, a respected and trusted French Notified Body and CMDCAS registrar recognized by Health Canada. We’ve built our reputation on our expertise at both efficiency and your device. We are able to provide CE marking in accordance with all directives, including IVDs and ISO 13485 CMDCAS certification to all medical devices. In addition, we are also able to provide ExpressCert, our new program designed to put your device in the express lane! Our Standard Review Time is FasterG-MED NA’s expertise in efficiency means that our standard assessment time is one of the fastest in the industry! To take advantage of G-MED NA’s expertise in efficiency, whether you choose ExpressCert or not, fill out this form to receive a personalized quote!
ExpressCert – When Your Device’s Speed to Market is Critical
When your top priority is getting your device to the European or Canadian market, use G-MED NA’s ExpressCert! As soon as “the clock begins to run” (see timeframes above), we partner with you to start our engines.1 With ExpressCert, you can take full advantage of our streamlined, efficient review system by being in the express lane to certification. In addition, you can take advantage of G-MED NA’s characteristics like:
Can G-MED North America Really Assess My Device in 30 days?Yes! First, G-MED NA is responsible and makes sure it has the resources to devote to your device with ExpressCert before we get started so you don’t pay for something we can’t deliver. Then, G-MED NA makes a preliminary review of your device to determine if we need any more information. The clock starts as soon as we receive the last piece of information we need from you or at the end of the audit! As long as there are no major issues or nonconformities, within those 30 working days, you will receive the recommendation from our committee.2 To find out if you can put your device into the express lane, call us at (301) 495-0477 or fill out this form.
1 Our ability to accommodate ExpressCert certification depends on our capacity and how quickly you can provide us the required information we need to assess the regulatory compliance. If we can’t deliver our assessment conclusions within the time stated, we’ll tell you when you receive your quote from us or as soon as we know. 2 Note a positive result of our assessments (issuance of a certificate) within 30 days can not be guaranteed. |
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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.
