You are three easy steps away from submitting your CE Mark application!
First - complete the registration process providing us with information on your device and send it to CE Mark Express. CE Mark Express reviews the information on your device.
Second – If CE Mark Express can complete a suitable application we will let you know and provide an invoice for our services, (remember it is only $4995 USD). After receipt of your payment, CE Mark Express prepares the required forms, Technical File and Authorized European Representation contract, and gets this important information to you for your review, usually in three business days or less after receipt of your payment.
Third – When you are satisfied that the forms and application are complete and accurate (and there may be a need for additional information), you print the forms and applications, sign them and forward them our European offices Canada at the address we provide you. We do the rest!
The experts at CE Mark Express have successfully developed hundreds of regulatory applications on devices ranging from high volume disposables, cardiac implantables and In Vitro diagnostic test kits.
Receiving a CE Mark will open medical device regulatory doors right around the world!
