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The healthcare division of Network Systems and Technologies (NeST), part of the NeST Group of Companies based at Technopark here, has achieved the ISO 13485:2003 certification.
The company has already been certified by quality standards ISO 9001:2008, ISO 27001:2005, CMMI v1.2 Level 5 and Automotive SPICE to ISTQB accreditation, a company spokesman said here.
At a ceremony at Technopark on Wednesday, Mr R.A. Venkitachalam, Managing Director of Underwriters Laboratories, India, handed over the ISO 13485:2003 certificate to Mr N. Jehangir, Vice-Chairman and Managing Director, NeST Group of Companies.
Mr Jehangir said that the company was extremely proud to have been awarded the certification. “This demonstrates our passion for quality and our commitment to deliver software adhering to the world's best practices,” he added.
ISO 13485:2003 specifies requirements for a quality management system for which an organisation needs to demonstrate its ability to provide medical devices and related services. These should consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
NeST employs over 500 engineers in its healthcare division providing engineering services to some of the world's leading medical diagnostics equipment suppliers.
The certification will help the company expand services in North America and Europe by providing safer and smarter solutions in image processing, performance tuning and image analysing algorithms to R&D divisions of major equipment manufacturers, the spokesman said.
Mr Sasikumar, President, NeST, said that the milestone would project the company as a major player in the healthcare domain and facilitate growth.
According to Mr Venkitachalam, ISO 13485 is a key requirement in achieving compliance with global regulatory requirements for the healthcare industry.
NeST was awarded this certification after undergoing Underwriters Laboratories stringent assessment and review process.
Underwriters Laboratories is an independent product safety certification organisation that has been testing products and writing standards for safety for over a century. It evaluates more than 19,000 types of products, components, materials and systems annually with 20 billion Underwriters Laboratories marks appearing on 72,000 products.
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