Forget about the CE marking in your development process
I have met many businesses through the years, and I have noticed a fairly clear trend. Many people are earnest and do much of the
The CE mark is mandatory for most products sold in the European Economic Area (EEA) and Turkey. It ensures a higher level of product compliance to safety. Our experts help simplify obtaining a CE Mark and conforming to the various technical requirements.
Distance sellers and manufacturers of products and equipment that want to market, sell or put into service a product in the European Economic Area (EEA) must have each product approved for the relevant EU legislation.
The Zatisfy team has the expertise to assist you in approving (and CE marking) your products. Although the manufacturer carries the responsibility for all documentation, our experts will guide you through the process to ensure you have everything in order, saving you time and money.
We assist with (among others) the following products:
We help your business in 4 critical areas.
1. Technical File
A product’s technical file contains all relevant specifications, test reports, instructions for use, inspection certificates, and a declaration of conformity.
2. Declaration of Conformity
If a product needs to be CE-marked, the manufacturer declares that the product poses no safety threat to people, animals, and the environment under the applicable EU directives with this declaration. It can also be a Declaration of Performance or Declaration of Incorporation, depending on the product type.
3. Authorised Representative (AR)
With the help of our dutch subsidiary, www.24hour-ar.com, we can act as your AR so that, if you are placed outside the market, you can sell the product legally in the market. As your EU point of contact, we will handle several essential responsibilities on your behalf. You will use our address on all packaging and labelling.
4. Tests and reports
Products must undergo testing for product compliance and conform to various directives for safety and quality. Our experts will guide you on product requirements lists, certification, packaging, labelling, and lab testing.
The first step is to analyse the product to understand the relevant directives, regulations and standards it must comply with.
We determine all the documentation necessary for your specific product. Then we compile a list of missing documents required to complete the package.
After the gap analysis, we will help you prepare any missing documents to make the CE marking package compliant and ready for approval.
I have met many businesses through the years, and I have noticed a fairly clear trend. Many people are earnest and do much of the
A classic question you might think is, what does CE marking of a product really cost? Well, as a consultant, one should be able to
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