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Businesswire
J Mitra & Co. Awarded ICMED 13485 Certification
April 26, 2019
Business Wire IndiaJ 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.
Source: Businesswire
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.
Source: Businesswire
