ISO 13485
ISO 13485 Medical Device Quality Management System The medical equipment manufacturing sector is highly regulated, with materials for medical devices needing to adhere to numerous quality systems and product specifications. The ISO 13485 Medical Device Quality Management System Requirements Standard strengthens quality control in accordance with medical device regulations and incorporates key elements from both the US FDA and European medical device regulations. This certification aims to ensure compliance with diverse regulations and customer specifications, aligning an organization's quality management system with FDA quality control (QSR) and global regulatory standards.
ISO 13485 aids medical device manufacturers in developing, establishing, and maintaining effective quality management systems to enhance process efficiency. Organizations must showcase their capability to supply medical equipment and related services, assess potential risks in the medical device supply chain, efficiently control product quality, meet global customer requirements, and demonstrate compliance with regulatory requirements for related services. Our contribution spans the design, development, production, warehousing, distribution, installation, and provision of services for medical materials and related operations. We are committed to ensuring manufacturers consistently produce, install, and deliver safe and purpose-fit medical devices.
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