ISO 13485:2016 is a global standard specifying the requirements for a robust quality management system (QMS) tailored to the medical device industry. It emphasizes an organization’s ability to consistently fulfill both customer and regulatory requirements for medical devices and associated services, ensuring high standards of quality and compliance throughout the product lifecycle.

Benefits of ISO 13485:2016 Certification

ISO 13485:2016 certification enhances the quality of medical devices by ensuring adherence to stringent standards. It supports regulatory compliance, minimizes risks through effective management practices, and boosts customer confidence by demonstrating a commitment to high-quality and reliable products. The certification also promotes continuous improvement, ensuring ongoing adherence to industry best practices and evolving regulatory requirements.