QCI-AiMed enhance ICMED Scheme with introduction of ICMED 13485 Plus!

The Quality Council of India(QCI) and the Association of Indian Manufacturers of Medical Devices (AIMed) have enhanced the ICMED Scheme with the introduction of ICMED 13485 Plus!

This innovative scheme marks a significant milestone in ensuring the quality, safety, and efficacy of medical devices. By integrating Quality Management System components and product-related quality validation processes, ICMED 13485 Plus sets a global benchmark in the industry.

Why is this scheme a game-changer?

• First-of-its-kind integration of quality management systems and product certification standards with regulatory requirements.
• End-to-end quality assurance for the medical devices sector in India.
• Addresses challenges such as counterfeit products and sub-standard devices, ensuring patient safety.
• Paves the way for India to emerge as a global leader in manufacturing top-quality medical devices.
• A voluntary scheme for medical device manufacturers who wants to stand out among their competitors.

MB Bureau