Intertek Launches New Restricted Substance Compliance Assurance Programs for the Medical Equipment Industry
30 Oct 2008
Intertek (www.intertek.com/rohs), the leading provider of quality and safety solutions to a wide range of industries worldwide, has today launched new training and implementation programs to help the Medical Equipment Industry meet a number of new restricted substances requirements.
New limitations for restricted substance in medical devices worldwide include the pending expiration of the current general exemption for medical equipment under the European Union’s RoHS legislation, requirements to disclose Substances of Very High Concern (SVHC) under the EU’s new REACH regulation, and the inclusion of medical products in the Electronic Information Products (EIP) list for China RoHS.
The changes will force medical device and equipment companies to convert their products to become restricted substance (RoHS, SVHC) compliant, which may include finding replacement parts and substances for existing components, and change their compliance monitoring and testing across the chain of supply and production. New compliance requirements can introduce additional costs and slow down production or ‘time-to-market’ if a company can not effectively build the changes into their supply-chains. Intertek‘s new training and implementation programs are tailored to medical equipment companies and will help them understand the new Restricted Substances laws, to comply with them, and to do so efficiently and effectively.
Education will be offered both on-line through Webinars and through on-site training. The training and implementation modules will include overviews of the Global RoHS Directives and the REACH Regulation, Engineering training to create restricted substance compliance files on products; Internal Auditor training for RoHS Compliance and Incoming Inspection Procedures; Supplier Auditor training to ensure Suppliers meet restricted substance requirements; GAP Assessment and Corrective Action Plans to reach compliance; Risk-based XRF screening programs with interpreted test results; and Restricted Substances Process and Product Certification programs.
Tom Rainone, General Manager of Intertek Health & Environmental Services’ CMS unit, notes that, "Intertek-CMS has helped guide the Electrical and Electronics Industry through restricted substances compliance in recent years. As the medical equipment industry now faces a number of new changes, we are bringing our implementation knowledge to help them address the required transition without interrupting their normal design and business processes."
For additional information, please visit www.intertek.com/rohs and www.intertek.com/reach.
For additional information, please contact:
Joel Pekay
Global Marketing and Business Development Director
Telephone: 630-481-3126
Email: joel.pekay@intertek.com
About Intertek Health & Environmental Services (www.intertek.com/green)
Intertek Health & Environmental Services offers the complete solution for health and environmental compliance, providing sound traceability systems and strict enforcement of due diligence policies. Intertek H&E Services does more than simply help our clients comply, we give them the competitive advantage they desire. Intertek H&E Services offers comprehensive services for REACH, TSCA and California Proposition 65 including on-call consulting, product testing and analysis, Only Representative services and corporate education appropriate for all types and levels of business. Intertek H&E’s REACH services provide the necessary legal and technical management of REACH requirements in the EU, representation in the EU and submission of REACH-related information to the EU. Intertek Ageus Solutions, a unit of Intertek Health & Environmental Services, is a leader in global environmental compliance, consulting, technology services and product stewardship.
About Intertek (www.intertek.com)
Intertek (ITRK.L) is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers' products and processes, supporting their success in the global marketplace. Intertek has the expertise, resources and global reach to support its customers through its network of more than 1,000 laboratories and offices and over 23,000 people in 110 countries around the world.