Product
Safety Testing


Intertek has the expertise to test everything from medical lasers and ultrasound equipment to life support systems. Whether it’s the ETL Listed Mark, S or CE Mark, CB Scheme, or testing to the Medical Device Directive (MDD), we provide the testing and certification necessary for global market access.

Learn more about our
product safety testing services

FDA 510K Reviews

We understand your need for faster turnaround on FDA 510(k) reviews and faster time to market. Fortunately, through our status as a third-party reviewer, Intertek is able to complete the 510k review process, on average, in under 15 days.



Learn how we can speed
your time to market

Top 10 Reasons Medical Devices Fail
Testing the First Time?

Whether it’s failure during EMC testing, wiring hazards, or not meeting packaging requirements, our white paper explains common pitfalls during the certification process and outlines steps you can take to save time and money.



Download your FREE copy
today!


Start a medical device testing project today!

or call 1-800-967-5352

About ETL SEMKO - The ETL SEMKO division of Intertek is a leader in medical device testing, medical device certification, and quality system registration for medical device manufacturers globally. Intertek’s medical industry experience and expertise coupled with the ability to test to a variety of international requirements simultaneously enables us to get your project done faster without sacrificing quality.  Whether you need electrical safety testing and certification, testing to the Medical Device Directive (MDD) or In-Vitro Diagnostic Directive (IVDD), or FDA 510k reviews our knowledge of international requirements will help you get your product to market faster.