product testing, risk analysis management, conformity assessment, ISO9000, certification services
ITS helps manufacturers of medical devices meet product safety, EMC and regulatory requirements for worldwide markets. For decades, we have been testing all types of medical devices for many different countries such as U.S., Canada, Europe, Australia, New Zealand, Japan, Russia, and South America.
We are very different from other testing laboratories.
- We partner with you to make sure your unique needs are met.
- We will educate you on medical device requirements.
- We know your products - our medical device compliance engineers are the best in the industry.
- We understand how important "time to market" is for your business.
- Test locally and sell globally - we have 58 locations throughout the world, with 22 labs in North America.
- And of course, we hold all the accreditations and provide all the services you need to sell your medical device on the global market.
- Product Safety Testing and Certification
- Performance Testing
- EMC Testing
- Assessment Services: design reviews, software, risk analysis, technical files and 510(k) submittals.
These are some of the reasons why our client list includes top companies such as: GE Medical, Picker International, Welch Allyn, Boston Scientific, Nicolet, Ohmeda, Boston Medical Technologies, Varian Oncology, ADAC Labs, Toshiba America MRI, and Shimadzu. As always, a complete listing of our clients is available upon request.
If you would like additional information, a proposal or if you have any questions, please call Nancy B. Medas at 978-635-8561, e-mail at nmedas@itsqs.com or visit our web site at www.etlsemko.com.