Patni achieves ISO 13485:2003 Certification

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Patni achieves ISO 13485:2003 Certification

Patni achieves ISO 13485:2003 Certification

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Patni Computer Systems, a leading global IT consulting and services provider, today announced that the medical electronics practice of its product engineering services business unit has achieved the ISO 13485:2003 certification, an international quality management standard for medical devices and related services. ISO 13485:2003 is a quality management standard that comprises best practices, in line with regulatory requirements across the world including US, Japan, Canada, the European Union, and several other countries. The US FDA recognizes this standard to be in line with its quality systems regulation (QSR).

ISO 13485:2003 is specifically oriented towards Requirements development, design and development, verification and validation, conversion, maintenance and documentation of medical devices for hardware and software. The ISO 13485:2003 certification indicates an organization's ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements.

A team of independent auditors from Det Norske Veritas (DNV) conducted a detailed inspection of Patni's Quality Management systems and processes before recommending Patni for this certification.

Mr. Ajay Chamania, Senior Vice President, Product Engineering Services, Patni said, "The ISO 13485:2003 certification opens up new markets for us all over the world and allows us to offer a broad range of innovative solutions from pacemaker programming applications to complete end-to-end product development for the medical devices and healthcare industry".

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