Description

ICMED Plus is an advanced certification scheme developed by the Quality Council of India (QCI) and the Association of Indian Medical Device Industry (AIMED) to further enhance the credibility and traceability of medical device manufacturing in India. It builds upon the foundation of the ICMED scheme by incorporating additional requirements for product safety, performance evaluation, post-market surveillance, and regulatory compliance, aligning closely with global best practices. This certification demonstrates a manufacturer’s commitment to delivering high-quality, safe, and effective medical devices that meet both national and international regulatory expectations. By achieving ICMED Plus, organizations can strengthen brand reputation, gain competitive advantage, and facilitate easier market access across global markets. At GQA Consultants, we guide clients through the complete ICMED Plus certification journey — from gap analysis and documentation to implementation, training, and audit readiness. Our expertise ensures seamless alignment with QCI standards, helping manufacturers achieve excellence in quality management, patient safety, and product integrity.