
The standard provides a framework for the development, implementation, and maintenance of a QMS that is specific to the medical device industry. ISO 13485 covers all aspects of the medical device lifecycle, from design and development to production, installation, and servicing. It also includes requirements for post-market surveillance, risk management, and documentation.
One of the key features of ISO 13485 is its focus on risk management. The standard requires companies to identify, assess, and mitigate risks associated with their medical devices throughout their lifecycle. This includes risks related to product design, production, and use, as well as risks associated with the supply chain and distribution.
ISO 13485 also requires companies to have a comprehensive quality manual that outlines their quality policies and procedures. The quality manual must be regularly reviewed and updated to ensure that it remains relevant and effective.