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 ...

Accredited Consultants Pvt. Ltd We are an ISO 10002:2004, ISO 9001:2008 Company and India’s most trusted management consulting firm with over 15 years of experience in the business. We collaborate with visionary leaders, institutions, ministries, research organizations & regulatory bodies from all sectors and spectrum to help you enter India’s vibrant market with most suited and in-depth strategy ...

7.5.1.1 General requirements The manufacturer shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:— (a) the availability of information that describes the characteristics of the product; (b) the availability of documented procedures, documented requirements, work instructions; and reference materials and refere ...