Description

The Indian Certification for Medical Devices (ICMED) is a quality assurance framework established by the Quality Council of India (QCI) in collaboration with the Association of Indian Medical Device Industry (AIMED). It aims to strengthen the quality, safety, and reliability of medical devices manufactured in India while promoting global competitiveness and regulatory compliance. ICMED provides a structured evaluation system that combines product certification and quality management system requirements, ensuring that manufacturers adhere to internationally recognized standards such as ISO 13485. This certification enhances customer confidence, supports regulatory approvals, and demonstrates a strong commitment to consistent product performance and patient safety. At GQA Consultants, we assist medical device manufacturers in obtaining ICMED 9000 and ICMED 13485 certifications through end-to-end consulting services — including documentation development, system implementation, internal audits, and readiness assessments. Our goal is to help organizations achieve certification efficiently while ensuring long-term compliance and operational excellence.