Patni achieves ISO 13485:2003 Certification

Patni Computer Systems Ltd on December 18, 2006, has announced 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 & development, verification & 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 the Company's Quality Management systems and processes before recommending the Company for this certification.

Mr. Ajay Chamania, Senior Vice President, Product Engineering Services of the Company 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".

The Company delivers a range of product engineering services for the medical device industry for product categories such as therapeutic, diagnostic and patient monitoring devices by leveraging its strong medical domain expertise and broad range of technology capabilities in areas such as Software, Hardware and Embedded technology, hardware design, firmware development and product testing and verification.

The Company has a very strong and robust quality framework for medical devices product development, testing and support. The Company has facilitated some of the biggest medical devices Companies to bring out high quality products relatively early into the market.

Source : Equity Bulls

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