Ce marking process and approval meddevicecorp

1. CE marking and CE certification For Medical Device CE marking and CE certification what is it why you need it who can apply Who Can Apply For CE Marking? Are you a business man or an electronic and medical device manufacturer? You will come to know about CE marking and its CE certification. But in some cases most of these people will not come across its importance, Why we need, What it does, how to apply, who can apply, and more and more things. They just only do it as a normal process. When they start knowing its importance, it helps their business growth as well. Read below my article to make my above-said words true. Learn How To Do CE marking: Steps to CE marking by the CE marking consultants: 1. Identify the relevant directives and its standards, 2. Verify the product’s specific requirements, 3. Identify whether an independent conformity assessment (Notified Body Medical Device) is necessary or not, 4. Test the product, 5. Create the technical documentation, and 6. Finally, Add the CE mark to the specific product. What are the CE Marking and CE certification?

2. CE marking became standard to prove the devices' safety among its environment. In short CE marking is a certification given to any devices like electronic items and medical devices, to assure its safety around the human and living environment and to make sure that the people and kids are safe from it. Why Does This Certification Require? CE marking for the electrical, electronic and medical device says that the manufacturer claims that a product meets all the essential requirements of all relevant European Medical Device Directives and makes it ready for its usage to the customers. 8 Interesting Thing About CE Marking and its Certification: 1.The CE mark is a mandatory conformity one marking for certain products sold within the European Economic Area (EEA) since 1985 2.CE marking is the self-declaration where a manufacturer proves compliance with EU safety, health, and environmental protection legislation and confirms a product’s compliance with relevant requirements 3.The authorized or manufacturer representative must keep technical documentation for several years (the number is dependent on the product type) after the last product has been placed on the market 4.Each EU country is responsible to enforce the CE marking, by banning products and levying fines for non-compliance

3. 5.Unsafe products are shared in the EU via RAPEX – a rapid alert system on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers 6.There is a very similar logo where the CE stands for Chinese Export or China Export and this has nothing to do with European conformity 7.The size of the CE mark must be at least 5 mm high. If the appearance or size of a product do not allow for the CE marking to be affixed on a product itself, the marking has to be affixed to its packaging or accompanying documents MedDeviceCorp has tested and provided thousands of products to support CE Marking and CE certification for product safety, electromagnetic compatibility, and energy efficiency. Contact us today to tap the experience and skill of our CE expertise team and get quick Medical Device CE Marking. WE EXTENDED OUR SERVICES IN SERVING: ● CE Marking ● ISO 13485 ● FDA 510(k) ● Cleanrooms ● GMP certificate ● Drug Master File ● US FDA Registration, and etc. Visit: http://www.meddevicecorp.com/ Call +44 2037594094 75 Executive Drive, Suite 303, Aurora, Illinos – 60504 FB: https://www.facebook.com/meddevicecorp Twitter: https://twitter.com/meddevicecemark Linkedin: https://www.linkedin.com/company/meddevicecorp/ Instagram: https://www.instagram.com/meddevicecemarking/