Medical DeviceQualified Supplier Directory

Intertek

70 Codman Hill Road
Boxborough, 
MA  01719  us
Tel: 978/635-8616
Fax: 978/231-8932

Intertek has more than 50 years of experience in the medical industry, offering a global network of twenty labs specializing in medical device testing. The company has the technical capability and knowledge of changing requirements to test when, where, and how it's needed, to get a device to market faster than ever. Intertek offers third-party product safety testing and certification to meet various safety requirements including ETL Listed Mark in North America and the S Mark and CE Mark in the European Union. With the CB Scheme Intertek can help you access more than thirty countries with a single certificate. Services include electrical safety testing for medical devices; medical device safety standard IEC 60601-1 3rd Edition; FDA 510(k) Reviews; FDA Accredited Persons (AP) Inspection Program; CE Marking and EMC Testing for medical devices; health and environmental compliance; In-vitro Diagnostic Directive (IVDD); and Medical Device Directive (93/42/EEC) The company also offers online product design reviews for medical devices, performance testing, accelerated stress testing for medical devices, and medical management systems auditing and certification.