India’s first biocompatibility & medical device testing lab
The government of India is taking all steps to improve the medical device sector of the country. The Gujarat Food & Drugs Control Administration (FDCA) gets the allocation of 15 Cr to set up first government biocompatibility and medical device testing lab in India. Commissioner of Gujarat FDCA, Dr Koshia said: “The testing lab will address […]
Med Tech Manufacturers forced to consider ISO 13485 Standards
ISO 13485 defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article that is intended by the manufacturer to be used alone or in combination. Registration with ISO 13485 requires the manufacturer to implement an integrative management system which complies […]