7 Steps - How to Get a CE Marking Certification for Medical Devices?
Are you Looking for a CE Certification of Medical device?
If yes then! You are at the right place, We have a Testing and Certification Body for Medical Equipment, We will provide you CE Certificate and Testing Service for Your Medical Equipment as per the Applicable directive: Directive (93/42/EEC)
If You Have Any Requirement For CE Certification
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In This article, we are explaining 7 Steps - How to Get a CE Marking Certification for Medical Devices?
There’s a common misconception among many medical device manufacturers that Getting a CE Certification is too hard, too costly, and too complicated. We’re glad to be able to say that this isn’t true. With some knowledgeable guidance and the understanding that Getting your CE Certificate is simply a process like any other, much of the undue stress and worry can be taken away.
In this article, we will walk through some of the key steps in obtaining a CE marking Certification for medical devices – along with some necessary additional steps for manufacturers located outside of the European Union.
Step 1: Classification
Step 2: Identification
Step 3: Technical Documentation
Step 4: Appointing a European Authorized Representative.
Step 5: Certification
Step 6: Affixing the CE Marking
Step 7: National Provisions
The final step is complying with the national requirements In order to introduce a medical device into several European Union countries such as France, Greece, Italy, Latvia, Portugal, the manufacturer has to complete an additional registration with National Competent Authorities.
We are perfectly situated in Europe, to provide advice and help on the CE marking Certification process and act as your European Authorized Representation. Contact us today to find out how Our’ Expert Consultants can be of assistance in the compliance process.
If You Have Any Requirement For CE Certification?
Please feel free to contact us
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