ISO 13485:2016 is an international standard specifically designed for quality management systems (QMS) within the medical device sector. It outlines the requirements for establishing, implementing, maintaining, and improving a QMS that focuses on the safety and effectiveness of medical devices throughout their lifecycle.
Benfits of ISO 13485:2016 Certification:
ISO 13485:2016 Certification ensures regulatory compliance, enhances product quality, and improves risk management for medical devices. It boosts customer confidence, streamlines processes, facilitates market access, and fosters continual improvement, reinforcing your organization’s commitment to safety and effectiveness.
