Intertek helps Instrumentation Laboratory bring medical devices to the EU marketplace
10 Nov 2014
Kalundborg, Denmark - Intertek (www.intertek.com), a leading provider of quality and safety services to industries worldwide, has successfully completed the application process for an exemption, under the EU RoHS Directive, on behalf of their customer, Instrumentation Laboratory, Bedford, MA USA. This exemption covers proprietary blood gas analytical instruments currently being supplied to hospitals, clinics and laboratory around the world, and will ensure the customer continued access to the EU market.
RoHS exemptions can be granted with a narrowly-defined application for products, where the elimination of a prohibited substance is either technically or scientifically unviable, or when available substitution produces more negative than positive effects on the environment, health, or consumer safety.
Director of Quality Engineering with Instrumentation Laboratory, Jim Richard, said “Intertek and Torben Norlem, assisted us in the successful execution of a complex RoHS exclusion request. From the drafting of the submission, to the negotiations with the technical reviewers and the management of the approval process, Intertek experts were quick to respond, highly professional and knowledgeable in the legal and political processing of our request”
In addition to preparing the application and supporting documentation, Intertek acted as the liaison between authorities and Instrumentation Laboratory to ensure smooth and continuous progress of the application, as well as, the successful facilitation of in-depth communication with external stakeholders.
Intertek helps companies meet the complex regulatory and legal requirements relevant to the RoHS exemption process for all types of equipment under the RoHS Directive. Intertek experts successfully minimize client risk through their broad expertise and depth of knowledge of the medical device industry as well as other equipment under RoHS.
Intertek services comprise of both applications for new exemptions as well as applications for renewal of existing exemptions. Intertek experts can conduct the initial assessment for the feasibility of submitting an application in addition to supporting the entire application process, including program management, documentation creation and strategic planning.
To learn more about the RoHS services offered by our team of experts and from the larger Intertek organization, please visit https://www.intertek.com/RoHS/.
For Market Inquiries:
Torben Norlem
Chief Counsel
Intertek Health and Environment
Intertek Group
Tel.:+49 (0)711 27311 189
Email: torben.norlem@intertek.com
For Media Inquiries:
Tracy Veale
Marketing Manager
Global Health, Environmental & Regulatory Services
Intertek Life Sciences
Direct: 905-286-4182
Email: tracy.veale@intertek.com
About Intertek
Intertek is a leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value for its customers by helping improve the quality and safety of their products, assets and processes. With a network of more than 1,000 laboratories and offices and over 36,000 people in more than 100 countries, Intertek supports companies’ success in the global marketplace, by helping customers to meet end users’ expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide.
Visit www.intertek.com
About Instrumentation Laboratory
Instrumentation Laboratory (www.ilus.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The company’s product lines include Critical Care systems, Hemostasis systems and Information Management systems. IL’s GEM® product offerings, part of the Critical Care line, include the GEM Premier™ 4000 analyzer with Intelligent Quality Management (iQM®), GEM Premier 3500, GEMweb® Plus Custom Connectivity, and complementary products GEM PCL Plus, a portable coagulation analyzer, GEM OPL CO-Oximeter, and GEMdraw arterial blood samplers. IL’s Hemostasis portfolio includes the ACL TOP® Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, comprised of the ACL TOP 700, ACL TOP 700 LAS, ACL TOP 700 CTS, ACL TOP 500 CTS and ACL TOP 300 CTS. IL also offers the ACL AcuStar®, ACL ELITE®, and other Hemostasis analyzers, along with the comprehensive HemosIL® line of reagents. IL is based in Bedford, Massachusetts.