Global medical diagnostics firm Randoxs operations in India have recently achieved registration to both ISO 13485: 2003 and EN ISO 13485:2012 for the manufacture of medical devices. The registrations were awarded by BSI Group India and covers the filing, packaging, labelling and distribution of In Vitro diagnostic test kits, reagents and analysers.
Speaking after the achievement, head of Randox India Brian Walsh said,
Randox has had a significant presence in India for over a decade and, since the opening of our manufacturing facility in Bangalore in 2012, we now employ almost 100 people across the country and have a very loyal customer base.
Our achievement of these registrations is further evidence that Indian confidence and loyalty in the Randox brand continues to grow. We are very excited for our future here, and for how we can contribute to healthcare in India.
Ensuring high quality standards in the healthcare and diagnostics industry is of vital importance to Randox wherever we have a manufacturing facility across the globe.
Randox are renowned for manufacturing products of exceptional quality and we aim to ensure that our standards are consistent throughout the world. We are therefore delighted to have been recognised for our standards in India.
Manufacturing to quality management standards such as ISO 13485: 2003 and EN ISO 13485:2012 also reinforces the confidence that our customers across India have in Randox and our products. As one of the worlds major growth economies, the scale of the market means there is always room for new business opportunities and we hope that these opportunities continue to grow.

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