We guarantee exceptional production quality with ISO EN 13485:2016
ISO EN 13485:2016, an internationally recognized standard, provides a valuable quality management system for organizations involved in the design, production, installation, and servicing of medical devices. This standard ensures that companies consistently meet customer and regulatory requirements, managing quality throughout the device’s life cycle.
By applying sound risk management processes, ISO EN 13485:2016 minimizes risks associated with medical devices. In the highly regulated medical devices industry, complying with this standard is essential to produce safe and effective devices fit for their intended purpose.