ISO 13485

A standard for medical devices that includes quality system requirements and encompasses design and development, manufacturing, documentation management, procurement, and other quality management system requirements related to medical devices.

ISO 13485 is an international standard that specifies the requirements for quality management systems of market operators involved with medical devices. This standard is designed to provide medical device manufacturers and healthcare service providers with a unified set of requirements to ensure the quality and safety of medical devices.

ISO 13485 outlines the requirements for managing the processes involved in the production of medical devices, the responsibilities of management, product quality control requirements, supplier relationship management, and documentation process requirements. It also takes into account the specific needs of the medical sector, including requirements for the design and development of medical devices, compliance with legal and regulatory requirements, and risk management.

Compliance with ISO 13485 serves as confirmation that a company adheres to the quality management system requirements for medical devices, contributing to the improvement of production quality and ensuring that medical devices meet regulatory requirements.

An ISO 13485 certification is often a key requirement in tenders for medical devices.