CE marking & FDA Certification - Meddevicecorp

What's the difference Between CE marking & FDA Certification? How to get this certification for medical devices.

When it comes to your knowledge of the importance of CE marking and FDA certification as a medical device manufacturer by CE Marking Consultants, your business-level will hit your dreamt place. Before knowing the difference between the stuff on CE marking and FDA certification. Let me tell you a quite and simple definition on them.

CE Marking:

CE marking was meant to certify the product to assure health, safety, and environmental protection. This CE marking is also found in the products of electronics, electricals, medical devices, and more devices. Everything to make sure safety from those devices.

FDA Certification:

Companies and Firms exporting products from the United States are often asked by foreign governments or foreign customers to supply the certificates for products which can be regulated by the Food and Drug Administration (FDA). It is also a kind of certificate prepared by FDA containing information about the specific product's regulatory and its marketing status.

The Main difference between CE marking and FDA certification:

•        While the CE mark is less difficult to obtain, it is a less powerful certification. FDA approval indicates that the device is approved for use in all parts of the world, while the CE mark has restrictions, sometimes even within the EU.

•        The CE Marking in the European Union and the FDA-approval process in the United States both perform the same functions, by namely assessing the efficacy and safety of the new devices. While FDA approval is significantly more expensive to obtain for a number of reasons like:

•        The documentation and certification required from investigators are much less efficient for FDA submissions than it is for the CE Mark

•        There are almost a number of rounds of questions with FDA-approval submissions than with those CE Mark

•        The review cycles are more about three times longer with the FDA than as for CE marking

•        the CE Marking can be obtained through a clinical evaluation by a reviewing of published data for existing equivalent devices, whereas FDA approval will always require full clinical trials.

•        For the clinical evaluation, the one and only the requirement is that the manufacturer conduct a postmarket clinical follow-up study once the CE Mark is given. However, this type of study is much more easier to get approval for and therefore much less expensive to conduct.

To get this CE marking and FDA certification we make it easy with CE marking and FDA 510k consultants from Meddevicecorp.

Our Consultants Specialized in offering:

● 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/

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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 businessman 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?

CE marking became standard to prove the devices' safety among its environment. It means European Conformity. 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

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

8.       Pre-testing in the early product development process can reduce cost and time to marketing

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/