Medical device design and manufacture is quite possibly one of the industries where process certification is most crucial. From small independent firms to medical manufacturing giants, becoming ISO certified is an essential step to forming a solid foothold in the industry.
The key standard for the medical device industry, ISO 13485 certification is sector-specific, with the full designation “ISO 13485, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.” Companies that establish and implement an ISO 13485 quality system are taking a world-class approach to the design, development, manufacture, distribution and servicing of medical devices. Registration to ISO 13485 requires accountability, compliance with regulations such as the U.S. Food and Drug Administration (FDA)’s Current Good Manufacturing Practices (CGMP), maintenance of documentation, and traceability of products.
While not specifically tailored to the medical device industry, ISO 9001 is a broad-spectrum quality management standard that can benefit businesses of all sizes and types – including the medical industry!
To learn more about these standards, visit their individual pages by clicking the links below.