ISO 13485 is a popular international standard for quality management systems (QMS) of medical device manufacturing and related services. The standard ISO 13485 requirements follow a process-based approach that enables the organization to carry out each and every process using the PDCA cycle. The ISO 13485 certification specifies the requirements in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device. Visit iso 13485 netherlands
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