
ISO 13485 resources
Learn more about our ISO 13485 quality management system.
Medical device manufacturing is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose.
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
This brochure can help you understand the importance of ISO 13485 for your business
The regulatory requirements for a medical device quality management system
This FAQ document aims to answer some key questions on ISO 13485:2016
Find out how ISO 13485:2016 had a positive impact on Trauson and their business
At BSI we offer training courses tailored to ISO 13485:2016 to help support and grow your business.