DiaSys India has been awarded the EN ISO13485:2016 QMS certificate on February 10, 2020, for its Mahape, Navi Mumbai facility. The audit was carried out extensively by TÜV SÜD South Asia under the scope of “Manufacturing & Distribution of In-Vitro Diagnostic Products (Biochemistry & Hematology Reagents, Rapid Test Strips) and Analyzers”.
Furthermore, DiaSys India will soon be among the only five IVD companies in India, which are certified for the ICMED 13485, the Indian Certification for Medical Devices - Quality Management systems for regulatory purposes. TÜV SÜD South Asia was the certification body for this, too.
The Government of India developed the ICMED 13485 certificate scheme. 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 the 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, as well as enhancing credibility and competitiveness.
This certificate will help our company to secure our position on the Indian market further and scale up our operations, as it enhances confidence among buyers.