Medical Device Certification

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, gaining Medical Device Certification is an essential step to forming a solid foothold in the industry.

ISO 13485

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.

ISO 9001

Although not exclusively developed for the medical device industry, ISO 9001 is a widely applicable quality management standard that provides significant benefits to organisations of all sizes and sectors. It helps improve efficiency, enhance customer satisfaction, and ensure consistent quality—making it a valuable framework for businesses in the medical industry as well.

To learn more about these standards, visit their individual pages by clicking the links below.