Patni receives ISO 13485:2003 certification

New Delhi, Dec 18: Patni Computer Systems Ltd today announced the medical electronics practice of its product engineering services business unit has achieved ISO 13485:2003 certification, an international quality management standard for medical devices and related services.

ISO 13485:2003 comprises best practices, in line with regulatory requirements across the world including the US, Japan, Canada, the European Union and several other countries.

The United States Food and Drug Authority (USFDA) recognises this standard to be in line with its quality systems regulation (QSR).

''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,'' said the company's Senior Vice President (product engineering services) Ajay Chamania.

This certification indicates an organisation's ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements, he added.

The company delivers engineering services for the medical device industry such as therapeutic, diagnostic and patient monitoring devices.

UNI