Medical device iso 1348511/29/2023 ISO 13485 enables organizations to integrate their own QMS with medical device industry regulations. Medical device companies need their QMS to adhere to the ISO 13485 standard, which is specific to the medical device industry. Regarding QMS, there are two primary standards that are important, ISO 13485 and ISO 9001. These standards are issued by The International Organization for Standardization (ISO). QMS compliance is controlled by regulations, based on certain international standards. A compliant Quality Management System (QMS) is therefore absolutely fundamental for any medical device company, or any Life Science company operating in the tightly regulated healthcare space for that matter. Apart from meeting rigorous safety requirements, medical device manufacturers need to comply with strict quality standards.
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