ISO 13485 Quality Management

May 2022

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 quality management system (QMS) to meet these comprehensive requirements. Adopting ISO 13485 provides a practical foundation for Tritech to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

Prof. Chris Hopkins said: “We were absolutely delighted when BSI advised we had reached the required standard to be awarded ISO 13485. Quality is at the core of everything we do at TriTech.”