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Although being registered does not fulfill the requirements of the various industry regulators – such as US Food and Drug Administration (FDA) – ISO 13485 is commonly used as the basis for regulatory requirements. Contact us to learn more.įrequently Asked Questions About ISO 13485 CertificationĬertification to the ISO 13485 standard is often a prerequisite if you want to sell your medical device and/or IVD outside of the United States. Whether you are looking to obtain first-time conformance or transition/upgrade an existing QMS to ISO 13485:2016, our experienced consultants can help.
#ISO 13485 STANDARDS FULL#
Oriel STAT A MATRIX offers a full range of ISO 13485 consulting and training solutions for companies of all sizes. Unlike ISO 9001, which requires organizations to demonstrate continual improvement, ISO 13485 requires only that an organization demonstrate that a quality system is implemented and maintained. ISO 13485 is based on ISO 9001 and supplemented with additional requirements relating to design, special processes, environmental control, traceability, documentation records, and regulatory actions.
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ISO 13485 is the harmonized quality system standard for medical device manufacturers, their suppliers, and other third parties that provide products or product components, including QMS-related services for the company.