Product standards for medical device (1) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time. (2) Where no relevant standard of any medical device has been laid ...

Measurement, analysis and improvement 8.1 General The manufacturer shall plan and implement the monitoring, measurement, analysis and improvement processes needed— (a) to demonstrate conformity of the product; (b) to ensure conformity of the quality management system; and (c) to maintain the effectiveness of the quality management system. This shall include determination of applicable methods, in ...