The Medical Device Rules 2017 had come into force with effect from 1st day of January, 2018, and there have been various amendments over the past few years to make the industry better equipped for providing best in class medical equipment. With 1866 medical devices classified under 24 broad categories, Qualitek Labs is aware of the numerous requirements for different Class of Medical Devices and the associated tests related to General Safety, Electrical Safety, EMI and EMC compliance, as well as other requirements with reference from close to 1500 BIS standards applicable to the industry.
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