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BIS publishes IS 23485 Medical Devices – Quality Management System requirements and Essential Principles of safety & performance for Medical   Devices

BIS publishes IS 23485 Medical Devices – Quality Management System requirements and Essential Principles of safety & performance for Medical Devices


IS 23485 Medical Devices – Quality Management System requirements and Essential Principles of safety & performance for Medical   Deviceshas been formulated by amalgamation of  of ISO 13485 : 2016, 16142-1 : 2016 & 16142-2:2017.

Implementation of this standard by an organization would encompass compliance to “essential principles of safety and performance as well as to QMS requirements; which include risk evaluation and management for the designing and manufacturing of medical devices, clinical  evaluation, bio compatibility verification, environmental effects’ assessment, software validation and other safety and performance related aspects likely to be encountered during entire life cycle of a medical device.

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