Company Profile | January 1, 1996

product testing, risk analysis management, conformity assessment, ISO9000, certification services

Source: ETL SEMKO, a division of Intertek Testing Services (ITS)
product testing, risk analysis management, conformity assessment, ISO9000, certification services
Intertek Testing Services (ITS) is the world's largest products and commodities testing organization, providing testing, inspection and certification services to a wide range of industries.

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.

We offer a comprehensive list of services so you can meet worldwide requirements:
  • Product Safety Testing and Certification
  • Performance Testing
  • EMC Testing
  • Assessment Services: design reviews, software, risk analysis, technical files and 510(k) submittals.

We have the accreditation you needs to sell your products worldwide. To meet your North American market entry needs, we are an OSHA recognized Nationally Recognized Testing Laboratory, we are authorized by the FDA to review 510(k) submittals and we are accredited by the Standards Council of Canada as a Certification/Testing Organization. For CE marking your medical device we have Notified Body Status in Europe and for selling your product to over 33 countries around the world, we are a National Certification Body in the worldwide CB Scheme.

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.