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J Mitra & Co. Awarded ICMED 13485 Certification

  • Friday, April 26, 2019 2:40PM IST (9:10AM GMT)
 
New Delhi, Delhi, India:  J Mitra & Co., India’s leading In-vitro Diagnostic Company, has been awarded the ICMED 13485 Certification for its New Delhi based facility. Indian Certification for Medical Devices (ICMED) Certification is India’s First indigenous quality assurance system, and is at par with international and globally accepted quality certifications. The extensive quality audit was conducted by M/s TUV SUD South Asia Private Limited.

J Mitra & Co. already has ISO 9001:2015, EN ISO 13485:2016, WHO-GMP and CE certifications in line with its exceptional high-quality standards and is exports to more than 45 countries worldwide.

ICMED has been developed jointly by the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB), with Association of Indian Medical Device Industry (AIMED). It is especially effective for made-in-India and made-for-India medical devices. This significantly increases patient safety, reduces costs and time for launching newer solutions, while enhancing credibility and competitiveness.

The facility was audited on stringent parameters pertaining to various facets of its business including Design, Manufacturing & Marketing of Rapid, Elisa, Confirmatory, Blood Grouping & Fluorescence Immunoassay based IVD test Devices.

Speaking on the occasion, Jatin Mahajan, Managing Director, J Mitra & Co. said, “Quality is the foundation of our business. We are a made-in-India / made-for-the-world product company, and it is imperative that we conform to all established and credible quality standards. This certification will ensure that we are able to launch newer products more quickly for the Indian market, and at comparatively lesser cost – a great motivation for our ongoing efforts.


About J Mitra & Co.

J Mitra & Co. is India’s Leading In-Vitro Diagnostics manufacturing company. Incorporated in 1969, this research-based biotechnology company has just completed 50 years of its mission to serve mankind. Apart from a pan-India footprint, it is also the biggest exporter of diagnostics kits from India, and export to more than 45 countries across the entire globe. The company has more than 55 patents, the highest in its segment, a testimony of its extensive research-based operations.

J. Mitra & Co. is the pioneer in manufacturing and marketing of IVD test kits in India. It is the tradition of quality and seriousness of purpose that has led to a sterling and harmonious growth and an enviable recognition that extended far beyond its frontiers. The company manufactures a range of tests for infectious diseases like HIV, HBV, HCV, Dengue, Malaria, Typhoid, Leptospira in rapid and ELISA test formats. The other products include a range of anti-Sera products and confirmatory tests like Western Blot for HIV.
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