Mumbai, 14th June, 2018: Transasia Bio-Medicals Ltd., India’s leading In-vitro Diagnostic Company, has received ICMED 13485 - Indian Certification for Medical Devices (ICMED) Certification Scheme. The company has been audited and registered by UL India Private Limited. With this accreditation, Transasia becomes the first in the IVD segment to receive this certification.
Transasia offers solutions and products in Biochemistry, Hematology, Coagulation, ESR, Immunology, Urinalysis, Critical Care, Diabetes Management, Microbiology and Molecular Diagnostics. It provides reliable, affordable and innovative medical diagnostic systems to over 35000 customers and has an impressive install base of above 65,000 equipments in over 100 countries.
ICMED is the country’s first indigenous quality assurance system for India manufactured medical devices. It is an initiative of Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB). ICMED is aimed at enhancing patient safety, by providing the product credentials to manufacturers and is intended to significantly eliminate trading of sub-standard products or devices.
Transasia received the ICMED 13485 certification for its manufacturing facilities at Mumbai, Daman and Baddi. All the three facilities were successfully audited for quality compliance for the design, development, manufacture, installation and service of IVD analyzers and reagents used in diagnosis.
“We are proud and happy to be the first in the IVD Industry to receive this certification. We are glad that along with all existing national and international quality certifications we are now also certified by India’s very own QA system. The ICMED 13485 certification is an assurance of our focus on continuous improvement of our systems and processes, leading to greater customer satisfaction.” said Transasia’s Chairman & Managing Director, Suresh Vazirani.
He further added,
“The Indian medical device industry has long needed its own quality assessment system. I am grateful to QCI and NABCB for their joint efforts in making ICMED 13485 a reality. It a boon for IVD manufacturers like us, as it will bring down the substantial time and monetary investment to obtain globally accepted quality certifications. It will also give a boost to the ‘make in India’ focus on this industry. From the customer’s perspective, it will help in assuring standardized products.”
For over three decades, Transasia has been delivering the highest quality of IVD instruments and reagents, not just in India but also globally. Infact it was the first company to attain the CE certification and enter the European market, way back in the 1990s. Over the years, Transasia has been successfully certified as compliant and adherent to all international regulatory norms, and has well established documentation and procedures.
About Transasia Bio-Medicals Ltd.
Founded in 1979, Transasia Bio-Medicals Ltd., India’s Leading In-vitro Diagnostic Company offers products and solutions in Biochemistry, Hematology, Coagulation, ESR, Immunology, Urinalysis, Critical Care, Diabetes Management, Microbiology and Molecular Diagnostics.
Transasia provides doctors and patients with reliable, affordable and innovative Medical Diagnostic Systems, with an impressive install base of above 65,000 equipments across India. It has a vast network of the more than 250 service engineers, 400+ sales and marketing team, 23 zonal offices and 350+ distributors.
It is the first Indian company to manufacture and export blood analyzers and reagents, in the 1990s. Today, Transasia’s indigenous research has resulted in development of state of the art, ‘Make in India’ products and technologies, enabling its products to be among the best in the world.
All along its journey spanning more than three decades, Transasia has been recognized for its commitment to healthcare. It has been conferred ‘Global Growth Company-2014’ by the World Economic Forum amongst many others.
Headquartered in Mumbai, Transasia is a part of the global Erba Diagnostics Mannheim GmbH Group. The Erba –Transasia Group has spread its footprint across USA, UK, Germany, Czech Republic, France, Italy, Russia and Turkey through various acquisitions.
Erba’s production sites in India, Czech Republic and USA and R&D centres in France, UK, India and Czech Republic form a hub for indigenous manufacturing of world class deliverables.Today, the Erba -Transasia Group serves millions across 110 countries.
For further information, kindly visit www.erbamannheim.com