ISO 13485 Certification
Introduction to ISO 13485 Certification ISO 13485 is an international standard designed for organizations involved in the design, production, installation, and servicing of medical devices. It outlines the requirements for a Quality Management System (QMS) specific to the medical device industry. Achieving ISO 13485 certification demonstrates a company’s ability to consistently meet regulatory and customer requirements while ensuring the safety and effectiveness of medical devices. Importance of ISO 13485 Certification This certification is a globally recognized benchmark for quality in the medical device sector. It enhances credibility, builds trust with customers, and facilitates access to international markets. ISO 13485 ensures compliance with regulatory frameworks such as the European Medical Device Regulation (MDR) and the U.S. FDA requirements. By implementing this standard, organizations can minimize risks, reduce recalls, and improve overall product quality and perfor...