RA Venkitachalam, MD, UL India Private Ltd hands over the ISO 13485: 1996 certificate to Dr. Shama Bhat, CMD, Bhat Bio-Tech India
Bhat Bio-Tech India (P) Ltd (BBI), a diagnostic kit and recombinant DNA technology firm in Karnataka received the ISO 13485: 1996 certificate from UL India Private Limited.
The company is the first diagnostic and biotechnology company in the country to receive this certification, sources from Bhat Biotech said.
The ISO 13485 is the certificate for medical devices, and is a prerequisite for receiving the CE marking and US FDA approvals.
R A Venkitachalam, managing director, UL India who gave away the certificate stated that certificates like WHO-GMP, ISO 9001: 2000 and now ISO 13485: 1996 are leading Quality Management Systems. UL India, an affiliate of Underwriters Laboratories Inc (UL Inc., USA) provides product Safety Testing Facilities as well as Quality Management Registration services with special focus on High Technology Manufacturing.
Dr Shama Bhat, chairman and managing director, Bhat Bio-Tech stated his growth which led from a single product in 1996 to more than 60 products in 2004.