Note: Configuration management is a means by which identification and traceability can be maintained. 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices In defining the records required for traceability, the manufacturer shall include records of all components, materials and work environment conditions, if these could cause the medical dev ...

7.5.3.1 Identification The manufacturer shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification. The manufacturer shall establish documented procedures to ensure that medical devices and in vitro diagnostic medical devices returned to the manufacturer are identified and distinguished from conforming pro ...

As a company, we have one of the largest number of briefs on Diagnostics & Medical Devices Regulatory work. We combine this with our in-depth knowledge of drug regulations and help our clients in preparation of pamphlets, brochures, etc. and ensure they are as per the guidelines prescribed by various government departments. Besides this, we also help our clients in preparing dossiers for obtaining ...