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Opto Circuits certifies to ISO 13485:2003

Our Bureau, BangaloreMonday, December 11, 2006, 08:00 Hrs  [IST]

Opto Circuits India Ltd; India's leading manufacturer of healthcare equipments, has been certified to ISO 13485:2003 from Underwriters Laboratories Inc. This certification enables Opto to meet its customer and regulatory requirements. ISO 13485:2003 is an International Standard to provide a "harmonized" model for quality management system requirements that satisfy International Medical Device Regulations. Medical device manufacturers need to ensure that all medical devices are safe, fit for their intended purpose and that their design and manufacturing quality management systems meet Regulatory requirements. This standard is recognized worldwide as an international standard. It also makes it easier to meet QSR requirements of US FDA. OCI's product profile includes sensors, probes, pulse oxymeters, patient monitoring systems and digital thermometers. In 2001, OCI acquired 60 per cent stake in Advanced Micronic Devices to market its equipments in India. OEMs contribute 80 per cent of sales while Medicaid contributes the balance.

 
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