2020-04-02: DiaSys India has been awarded the EN ISO13485:2016 QMS certificate for its Mahape, Navi Mumbai facility

DiaSys India has been awarded the EN ISO13485:2016 QMS certificate on 10th February 2020, for its Mahape, Navi Mumbai facility. The audit was extensively carried out by TUV SUD South Asia under the scope of “Manufacturing & Distribution of In-Vitro Diagnostic Products (Biochemistry & Hematology Reagents, Rapid Test Strips) and Analyzers”. DiaSys India will also soon be among the only five IVD companies in India today who have certified for the ICMED 13485, the Indian Certification for Medical Devices (ICMED) -Quality Management systems for regulatory purposes. TUV SUD South Asia was the certification body for this too. The ICMED 13485 certificate scheme was developed by the Government of India, its accredited certification bodies and the Indian Medical Device Industry represented by the Quality Council of India (QCI), the National Accreditation Board for Certification Bodies (NABCB) and Association of Indian Medical Device Industry (AIMED) respectively. This certification is based on the ISO 13485 - Medical devices – Quality management systems and is aimed to encourage Indian companies to manufacture quality medical devices and enhancing credibility and competitiveness. This certification will help our company in reaching out wider in the Indian market, and scale up our operations as it further enhances confidence among buyers.