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
CE marking is mandatory for most products sold within the European Economic Area (EEA). It ensures a higher level of compliance with safety requirements. Let our CE marking experts simplify the process of CE marking and compliance with various technical requirements.
We assist companies with CE marking and safety for a wide range of products.
Machines (mobile, stationary, standalone, safety-related systems, or production facilities) can be extremely complex or very simple. We have the experience and expertise needed to make your CE marking process straightforward.
This is our largest business area as it covers a wide variety of products. Everything from toys to personal protective equipment, electronic products, and products that do not require CE marking at all are included here.
If you import or manufacture similar products, we can support you on your journey towards legally compliant products.
We cover all areas of medical devices from Class I to Class III. Our internal and external experts can build your quality system and technical documentation from scratch to ensure you meet the requirements of the new MDR and IVDR.
CE marking is constantly evolving, and if you work with machine safety or medical devices and want to enhance your knowledge through training, you’ve come to the right place.
If what you do doesn’t fit within these business areas, contact us, and perhaps our extensive network of partners can help you. If you want to know more about Certify & Compy, click here.
Sellers and manufacturers of products and equipment who want to market, sell, or use a product within the European Economic Area (EEA) must ensure that each product complies with all relevant EU legislation.
The Certify & Comply team of consultants has the expertise to help you approve (and CE mark) your products. Although the manufacturer is responsible for all documentation, our experts will guide you through the process to ensure you have everything in order, saving you time and money.
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Vill du veta mer om vad CE-märkning kostar har vi skrivit en artikel om det här.
We assist your company in four critical areas
1. Technical file
A product’s technical file must include all relevant specifications, test reports, user manuals, inspection certificates, and a declaration of conformity.
2. Declaration of conformity
If a product needs CE marking, the manufacturer declares that the product poses no safety threat to people, animals, and the environment according to applicable EU directives with this declaration. It can also be a Declaration of Performance or a Declaration of Incorporation, depending on the product type.
3. Manufacturer’s representative
Through our subsidiary within the EU and UK, 24hour-ar.com, we can act as your representative so that products from outside the market can be sold to the EU and UK. As your EU/UK contact point, we will handle several essential responsibilities for you. You can then use our address on all packaging and labeling.
4. Testing and reports
Products must undergo testing to document their compliance with various safety and quality directives. Our experts will guide you on product requirements, certification, packaging, labeling, and testing.
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
Certify & Comply delivers world-class service to manufacturers, importers, and exporters who want to sell their products in European Union countries.
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