ISO 13485 is a globally recognized quality management system (QMS) standard developed specifically for the medical device industry. It outlines the requirements organizations must meet to demonstrate their ability to consistently design, develop, manufacture, and deliver medical devices and related services that comply with regulatory requirements and customer expectations. It applies to manufacturers, suppliers, and any organization involved in the life cycle of a medical device, including storage, installation, and servicing.
The standard is based on ISO 9001 principles but includes additional requirements tailored to the medical device sector, such as risk management, sterile manufacturing, traceability, and regulatory compliance. ISO 13485 focuses heavily on product safety and efficacy, emphasizing documentation, validation, and quality control processes.
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ISO 22000
ISO 9001
ISO 14001
ISO 45001
ISO 13485
ISO 22000
ISO 9001
ISO 14001
ISO 45001
ISO 13485
ISO 22000
ISO 9001
ISO 14001
ISO 45001
ISO 13485