Meddevicecorp: CE marking & FDA Certification

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.