What is ISO 13485?This standard represents the quality and system requirements that medical device manufacturers must incorporate into their management systems.
Like any ISO certification, medical device manufacturers wanting 13485 certification must first learn the requirements of customers and any regulatory agencies, as well as how to implement an ISO 13485 quality management system.
Working together with the FDA 21 CFR Part 820 and CFR Part 210/211, compliance to ISO 13485 requirements ensure quality, safety and effectiveness in the design and manufacture of medical devices and equipment. In some markets, ISO 13485 is a requirement to do business.
ISO 13485's second edition was released in 2003 harmonizing regulatory quality management systems around the world. While ISO 13485 is a stand-alone standard, it is based on ISO 9001, however it excludes some requirements of ISO 9001 that are not applicable for the medical device industry.
As part of an ISO 13485 quality management system, companies must address the issue of risk management during product development. ISO 14971 is used as a guidance document for risk management.
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