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CE Marking Certification For Medical Devices And Equipment On European Free Trade Market
Provide FDA, GMP and CE marking solution for product certification
CE Marking Certification Steps-Process
We assist in a methodical fashion your approach to obtain your product CE marked whether to the MDD or the IVD directive. The different steps are optimized to speed up the process and drastically reduce cost of the procedure.:
- Step 1 - Identify the New Approach Directive(s) that is applicable to your product. You can download these directives from the European Union website
- Step 2 - Identify the conformity assessment procedure. The conformity assessment procedure will differ depending on your product and the Directive.
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- Step 3 - Identify if there are any Harmonized European Standards applicable to your product. These are not always mandatory but recommended
- Step 4 - Ensure the product complies with the essential requirements of the Directive(s). Take appropriate measures to comply
- Step 5 - Identify whether independent assessment of your conformity to the Directive, is required from a Notified Body
- Step 6 - Maintain Technical Documentation. Your technical documentation should support your compliance with the requirements of the Directive
- Step 7 - Prepare the Declaration of Conformity and the required supporting evidence. Documentation should be available to Competent Authorities (EU Members) upon request
- Step 8 - Apply CE marking on your product, packaging and accompanying documentation as stated in the directive
CE Marking Certification Benefits
The EU introduced the CE marking label to make trade easier and cheaper between EU countries. It means that a company claims that their product comply with the minimum legal requirements for health and safety as notified in EU directives. CE marking demonstrates that your product meets the minimum requirements of all relevant applicable European Directives. Often customers will look for CE marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality that other products may lack.
- The company meets the requirements of all relevant European Directives
- The product can be legally sold within the European Union (EU) and the European Free Trade Area (EFTA)
- The product can move freely throughout the European Single Market
- The quality product meets designated minimum safety standards and therefore a minimum level of quality
Many products are covered by these EU directives, and to be marketed in many European countries it is a legal requirement. We can help your company achieve CE marking efficiently and cost effectively. For instance, we have developed comprehensive information for companies seeking CE marking for Medical Devices and equipment. Moreover, there are also several publications to guide you through the process. Our experts understand precisely what each Directive requires for each product in the different European countries.
More information about our consulting services for CE Marking
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Clients that our Xperts have helped!
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CERTIFICATION GUARANTEE
We offer “Total Satisfaction Refund Policy” for all eConsulting services that you purchase from CompetitiveXpert. If for any reason you are not satisfied with our eBusiness services or one of our experts, we will refund you. We will not charge you for our remaining time, and we will discontinue our collaboration. We are proud of our achievement, and want to show it through the explicit satisfaction of the clients that we have helped.
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CUSTOMER TESTIMONIAL
“Caliso was essential to siteROCK being registered under ISO 9000 in record time. They quickly and accurately assessed the readiness of siteROCK to pass the final audit by making the intellectual effort to really understand our business processes. This allowed us to focus our efforts on those things that were really needed both to improve our business and to obtain the certification…”
Dave Lilly
President
SiteROCK
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