Medical Device Testing and Certification

Speed of information and testing is mission critical for you and your medical device innovations.

You’ve designed your medical device to be state-of-the-art: faster, stronger, and better than the competition. Don’t settle for less when it comes to your device’s certification.

At Intertek, our expertise will help you meet the latest requirements and get your device to market faster than ever before. We have the capability and expertise to test when, where, and how you need it, with:

• A global network of twenty labs specializing in medical device testing
• Approvals that can help you reach more than thirty countries with a single certificate
• More than fifty years of experience in the medical industry

Our full suite of services includes:

• Electrical safety testing, to international standards such as IEC 60601-1 and the CB Scheme, assures buyers that your device will not harm the patient or end user
• Third-party FDA 510(k) reviews, Notified Body assessments for CE Marking, and Accredited Person (AP) inspections shorten review times and add valuable selling days
• Performance testing and benchmarking verify that your device outperforms the competition
• EMC testing ensures that electromagnetic emissions from other products will not affect the normal operation of yours
• Management systems certification to standards such as ISO 13485, ISO 14971, and ISO 9001 proves that you have documented systems in place
• Environmental compliance services help you conform with new and upcoming restricted-substance requirements
• Exclusive access to educational webinars and white papers keeps you on the cutting edge of the latest regulatory requirements
• Star of Life Ambulance Certification

There’s no one more prepared for the regulatory process than Intertek. Start your project today to spend less time interpreting regulations and more time designing innovative medical devices.