STEP BY STEP PROCESS FOR CE MARKING ON MEDICAL DEVICES
WHAT IS CE MARKING?
CE stands for “Conformité Européenne", which literally means "Europen Conformity".
The CE mark is a symbol that a manufacturer affixes to a product so that it can be sold in the EFTA & European Union (EU) single market. The mark is mandatory for products that fall under one of the 24 European directives and also it takes responsibility for the compliance of a product with all applicable European health, safety, performance, and environmental requirements.
STEP BY STEP PROCESS FOR CE MARKING ON MEDICAL DEVICES
STEP 1: Find the CE Marking Consultant
How will you know if your product requires a CE mark? The first step is to see if your medical device needs CE marking. But especially it is needed for all the medical devices.
STEP 2: Know the essential requirements for your medical device.
Each Medical device may require EU certified directives like ISO 13485, FDA 510(k), US FDA Registration, ISO 9001:2008, 510k submission, and so on. So make sure to analyze it with CE Marking Consultants.
STEP 3: Assess product conformity
How will you know that your product complies with the essential requirements in the applicable directives? You will need to test and document that your product conforms.
STEP 4: Create and maintain technical documentation
The technical documentation must be provided on demand to enforcement authorities & also needs to be kept up-to-date, especially when the product is modified.
STEP 5: Declaration of Conformity & affixing the CE mark
The document certifying compliance with CE marking and Declaration of Conformity is provided.
Note: Is that a BIG process? Don't worry, just skip all those steps and immediately contact Certified and Authorised CE Marking Consultants for quick & instant CE certification for all your Medical Devices at a merely reasonable cost.
Our Consultants Specialized in offering:
- CE Marking
- ISO 13485
- FDA 510(k)
- Cleanrooms
- GMP certificate
- Drug Master File
- US FDA Registration, and etc.
Visit: http://www.meddevicecorp.com/
Call +44 2037594094
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