CE Marking & CE Certification
CE Marking and Certification
CALISO offers quality consultation to help small and medium-size companies obtain product certifications, such as CE certification. The European Community (EC) has implemented a system to protect the health of consumers and users of manufactured products. EC Directives and harmonized standards were created to ensure conformity to safety and quality standards throughout all the member states of the EC. The directives are voted into laws by the respective countries. If you do not comply to this laws, it is the equivalent to breaking federal law in the US. A review of your product's certification can be requested by customs, competitors, or because of an accident. European distributors will typically request the CE certification before carrying your product. If you want to export your products to anyone of the following countries:
Among the companies we helped in their regulatory and compliance projects for FDA and CE:
- The Netherlands
- United Kingdom
- Chech Republic
Your products must comply with the applicable EC Directives, and bear a "CE Marking" as a mark of conformity and compliance. With the CE marking shown on your product or, if not possible, on the package, it can circulate freely throughout the member countries. The CE certification will also help you obtain authorizations, if required for your products (Medical), for non-CE countries.
How to obtain the CE Marking/Certification: (For medical devices see Medical Devices).
- Determine the applicable EC directives
- Determine the applicable harmonized standards and essential health and safety requirements.
- Identify and choose a Notified Body
- Determine and perform the appropriate conformity assessment procedure
- Incorporate the requirements into the device/system design
- Assemble the Technical File
- Prepare the Declaration of Conformity
- Affix the CE Marking
You want your product exported to Europe yesterday! You do not want the CE Marking to cost you an arm and a leg. Well, it may very well take forever and cost you both arms and both legs if you select the wrong conformity assessment route or a slow and costly notified body. The demand is great on the notified bodies so they do charge a premium, make you pay for any mistake, and "try' to fit you into their schedule.
CALISO can help expedite the process and minimize the cost. We work in close relationship with the most prestigious European notified bodies. So we will obtain the most competitive pricing and scheduling flexibility. We will also parallel process step 1-4 and steps 5-7, and achieve substantial time and cost savings for you. This fast-track approach in close working relationship with the notified body, will save you time, money, resources and most important of all, your product with be out there sooner. e-mail a description of your product so that we can tell you which conformity assessment to follow.
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