The ISO 13485:2016. standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485:2016. provides a practical foundation for manufacturers to address the medical device directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
ISO 13485:2016 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
Whether you are looking to operate internationally or expand locally, ISO 13485:2016. Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.