Preventive action: The manufacturer shall determine action to eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for-— (a) determining potential non-conformities and their causes, (b) evaluating the need for a ...

xi) Implantable medical devices and surgically invasive medical devices for long term use (a) Subject to clauses (b), (c) and (d), an implantable medical device or a surgically invasive medical device intended for long term use shall be assigned to Class C. (b) A long term use medical device shall be assigned to Class B, if it is intended to be placed into any tooth. (c) A long term use medical de ...

THE BUREAU OF INDIAN STANDARD (BIS) Is a national standards body in India that operates under the Ministry of Consumer Affairs, Food, and Public Distribution. It plays a vital role in ensuring the quality and safety of products and services. Its main function is to formulates and promote standards to ensure the quality and reliability of products, covering a wide range of industries and sectors. I ...