HCL Launches RoHS Compliance Management System For Medical Device Users
Center of Excellence to help customers navigate manufacturing impact of new environmental directive
Sunnyvale, CA (May 18, 2006) - HCL Technologies Ltd. ("HCL"), a leading global IT and technology enterprise, today announced that it has established a RoHS compliance management capability for users of medical device companies under its Global Life Sciences & Healthcare Practice.
The RoHS Directive (Restriction of the use of Hazardous Substances) is an EU directive intended to reduce the flow of certain hazardous substances into the marketplace by banning the use of a list of restricted substances in electrical and electronic equipment. The directive requires that all new electrical equipment shipped to the European market after July 2006 contain less than maximum levels of the substances such as heavy metals (lead, cadmium, mercury, hexavalent chromium) and bromated flame retardants (polybromated biphenyl or polyborminated diphenyl ethers).
The directive currently addresses medical equipment including radiotherapy equipment, cardiology, dialysis, pulmonary ventilators, laboratory equipment, in-vitro diagnosis equipment and other appliances for detecting, preventing, monitoring, treating, alleviating illness, injury or disability.
It is anticipated that the directive will cover all medical devices, including implanted and infected devices, in the near future.
Pradep Nair, vice-president and head of HCL's Global Life Sciences & Healthcare Practice, explained why the system has been launched: "Because medical device development involves years, not months, HCL works with and encourages its medical device customers to evaluate the impact of the directive on products now in anticipation of a revised directive," he said.
"RoHS represents a major potential expense to medical device manufacturers - not only from the penalties arising from non-compliance but also in the likely costs of any changes made in order to comply with the directive. We have developed the expertise in house as part of our ongoing efforts to provide critical counsel to our customers.
"The impact of the directive on medical device manufacturers is complex. It requires assessing the impact of possible changes on the reliability of products, monitoring suppliers, evaluating current designs, and which changes require validation."
HCL was the first Indian provider to be certified for ISO 13485:2003 for the design and development of medical devices and currently has engagements with
8 of the top 15 pharmaceutical companies. HCL partners with medical device companies to help meet a wide range of industry requirements, including RoHS, WEEE, EMI / EMC / ESD, prototyping, manufacturing, BOM optimization, testing and industry compliance. HCL's Global Life Sciences & Healthcare Practice integrates capabilities that include product lifecycle management, manufacturing execution systems and global supply chain systems to achieve RoHS compliance.
About HCL Technologies
HCL Technologies is one of India's leading global IT Services companies, providing software-led IT solutions, BPO and remote infrastructure management services. Having made a foray into the services domain in 1997-98, HCL Technologies focuses on technology and R&D outsourcing, working with clients in areas at the core of their business. The company leverages an extensive offshore infrastructure and its global network of 26 offices in 15 countries to deliver solutions across select verticals including Banking, Insurance, Retail & Consumer, Aerospace, Automotive, Semiconductors, Telecom and Life Sciences. For the twelve-month period ended 31 March 2006, HCL Technologies, along with its subsidiaries, had revenues of US $919 million (Rs 4,102 crore) and employed 29,948 professionals. For more information, please visit www.hcltech.com
