About ISO 13485:2016

ISO 13485:2016 is an international standard specifically designed for the quality management systems (QMS) of medical device manufacturers. It provides a framework for organizations to ensure their products consistently meet regulatory and customer requirements. This certification is essential for companies involved in the design, production, and distribution of medical devices.

The standard focuses on process control, risk management, and maintaining high levels of product quality and safety. It also emphasizes documentation, ensuring that manufacturers have clear procedures for product lifecycle management, from development to post-market surveillance.

Achieving ISO 13485:2016 certification helps companies demonstrate their commitment to quality, improve operational efficiency, and gain a competitive edge in the medical device industry. It also supports regulatory compliance in various global markets, facilitating smoother market entry.