Risks and benefits of the investigational medical device and clinical investigation (a) Anticipated clinical benefits. (b) Anticipated adverse device effects. (c) Residual risks associated with investigational medical device, as identified in the risk analysis report. (d) Risks associated with participation in the clinical investigation. (e) Possible interactions with concomitant medical treatment ...

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 ...

THE FOOD SAFETY and STANDARD AUTHORITY OF INDIA (FSSAI) Plays a pivotal role in ensuring food safety and hygiene standards across the country. Some of the key functions of FSSAI include laying down rules for food safety and quality standards to ensure the production, distribution, and consumption of safe and wholesome food. Accredited Consultants Pvt Ltd (ACPL) serves as a regulatory consultant, ...

THE FOOD SAFETY and STANDARD AUTHORITY OF INDIA (FSSAI) Plays a pivotal role in ensuring food safety and hygiene standards across the country. Some of the key functions of FSSAI include laying down rules for food safety and quality standards to ensure the production, distribution, and consumption of safe and wholesome food. Accredited Consultants Pvt Ltd (ACPL) serves as a regulatory consultant, ...