The Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have launched ICMED 13485 PLUS- a new ICMED Scheme which is a improved version for Certification of Medical Devices.
- The ICMED 13485 PLUS, as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices.
- ICMED 13485 Plus has been designed to integrate the Quality Management System components and product related quality validation processes through witness testing of products with reference to the defined product standards and specifications.
- This is the first scheme around the world in which quality management systems along with product certification standards are integrated with regulatory requirements.
- This scheme will be an end to end quality assurance scheme for the medical devices sector in India.
