Streamlined RoHS Testing services get medical devices to market faster
(May 23, 2013) ARLINGTON HEIGHTS, Il — Intertek, the leading quality solutions provider to industries worldwide, announces the opening of its North American Center of Excellence for RoHS Directive testing in Columbus, Ohio. This facility will help medical device manufacturers complete RoHS testing more quickly and efficiently in advance of the July 22, 2014 deadline for medical devices and ensure validity for their products to be sold throughout the European Economic area.
The European Union’s RoHS Directive (2011/65/EU), also known as RoHS 2, lays down rules on the restriction of the use of hazardous substances in electrical and electronic equipment (EEE). Products sold in the European Economic Area must bear a CE mark, which stands as the manufacturer’s declaration that the product meets the requirements of applicable directives. RoHS 2 will soon be an applicable directive for medical devices, meaning that by affixing the CE mark on a product, the manufacturer has tested the device and has demonstrated compliance to RoHS 2 in the Technical Construction File.
Intertek provides a RoHS 2 Technical Documentation Review and Creation service to assist manufacturers in meeting conformity assessment requirements. The new Ohio facility will allow Intertek to complete all CE marking requirements for safety and restricted substances including BOM review, XRF Testing and Wet Chemical analysis. Having these capabilities at one facility builds efficiencies, enhances time to market and reduces costs for customers.
“Intertek is 100% committed to providing clients with the fastest, most efficient path to testing and certification,” said Sunny Rai, Regional Vice President, Intertek. “By creating this North American Center of Excellence where all RoHS 2 capabilities can be delivered under one roof, alongside the existing product safety expertise, we further simplify the process for manufacturers to meet the European CE Marking requirements for Safety and Restricted substances.”
Intertek is dedicated to providing the resources for manufacturers to get up to speed with the changing RoHS 2 Directive and what that means for CE Marking. In addition to building the Ohio facility for more streamlined testing, Intertek is sponsoring educational Lunch & Learn seminars and webinars across North America to ensure manufacturers understand the requirements and can enter global markets with speed and ease.
For more information on Intertek’s RoHS 2 compliance solutions for medical devices:
www.intertek.com/medical/regulatory-requirements/rohs
About Intertek
Intertek is the leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value to customers’ products, processes and assets. With a network of more than 1,000 laboratories and offices and over 35,000 people in more than 100 countries, Intertek supports companies’ success in a global marketplace. Intertek helps its customers to meet end users’ expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide. Visit www.intertek.com
Contacts
Intertek
Sunny Rai, + 1 650-463-2950
Regional Vice President
sunny.rai@intertek.com
