Your medical device has the same intended use and many physical and performance similarities(or nearly ) with a medical device that has already been admitted to the US market. In that case, you can obtain access to the US market from the FDA by following the so-called 510(k) process.

KEMA is one of the third parties with permission to implement this 510(k) process on behalf of the FDA. The biggest advantage of this is that the 510(k) process via KEMA is faster than via the FDA itself. This means your time to market is weeks – and sometimes even months – shorter with KEMA!

KEMA: a shorter time-to-market!

Besides the fact that you can put your medical device on the US market faster, KEMA’s 510(k) Third Party Review Program offers you even more advantages. 

• One-stop shopping. You can call on KEMA for such things as 510(k) and ISO 13485:2003. That makes a big difference in terms of time and money. All your testing and certificates at one institute: KEMA
• You can deliver your products in Europe. 
• KEMA can simultaneously take care of approval for the US and the European markets. 
• You have a local contact person.         

For more information please contact  us.