ISO 13485 is a globally recognized Quality Management System (QMS) standard specifically designed for medical devices. It focuses on risk management, process control, and maintaining safety and efficacy throughout the lifecycle of a medical device.

British companies in medical device manufacturing, pharmaceuticals, and related sectors can benefit from ISO 13485 by ensuring compliance with global regulations, reducing risks, and improving product quality and patient safety.

Implementing MDMS digitally with iCompliance simplifies the process by automating documentation, risk management, and compliance tracking. This approach minimizes human error, optimizes resources, and enhances control over the entire product lifecycle, making ISO 13485 implementation more streamlined and effective.