«CE MARKING» means the implementation of all those activities that allow the manufacturer to demonstrate the fulfilment of the regulatory requirements (Laws, Directives, Regulations, Etc.) and normative requirements (harmonized standards) to place his devices on the market.
The process of CE marking is an articulated path which requires a wide knowledge of the sector, specific expertise, knowledge of the manufacture processes, knowledge of the norms and the law, and of course, knowledge of the products.
On the basis of the products rating, different requirements are previewed. The most known are:
Having a SINGLE INTERLOCUTORthat can help you from the beginning of the path, untill obtaining the CE marking from the notified bodies, is undoubtedly priceless, in terms of time, strategy and costs
MEQUIPE offer its 30-year experience in the product and system certification sector, especially in the medical field, for:
- WRITING COMPLETE TECHNICAL FILES,
- TESTING (electric safety test, electromagnetic compatibility, radio, etc.)
- Designing and implementing the MANAGERIAL SYSTEMS that are more suitable for you (ISO 9001, and/or ISO 13485 and Directive/Regulation).
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