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J Mitra receives ICMED 13485 certification

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The facility was audited on parameters pertaining to facets of business including design, manufacturing, marketing of rapid, elisa, confirmatory, blood grouping and fluorescence immunoassay based IVD test devices

J Mitra, an in-vitro diagnostic company, has been awarded the ICMED 13485 certification for its New Delhi based facility. Indian Certification for Medical Devices (ICMED) certification. The extensive quality audit was conducted by M/s TUV SUD South Asia.

Speaking on the occasion, Jatin Mahajan, Managing Director, J Mitra 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.

J Mitra has ISO 9001:2015, EN ISO 13485:2016, WHO-GMP and CE certifications. in line with its standards and exports to more than 45 countries worldwide. The facility was audited on stringent parameters pertaining to various facets of its business including design, manufacturing and marketing of rapid, elisa, confirmatory, blood grouping and fluorescence immunoassay based IVD test devices. 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.

 

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