Omnex Medical Devices Services

ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. ISO is the International Organization for Standardization (, an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards, headquartered in Geneva, Switzerland. Requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size and can be used by any organization involved in one or more stage(s) of the life-cycle of a medical device.

The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for QMSs. Compliance with ISO 13485 is often recognized as the first step in achieving compliance with European regulatory requirements. The Standard excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements so organizations whose QMS conforms to ISO 13485 cannot claim conformity to ISO 9001 unless their QMS also conforms to all the requirements of ISO 9001. QMSs are not equivalent to product and service standards. If any requirement(s) is/are not applicable due to the nature of the medical device(s) for which the QMS is applied, the organization does not need to include such a requirement(s) in its QMS. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the QMS.

Learn from Omnex's QMS experts on how to implement and/or audit ISO 13485 systems including risk management methodology with disciplined problem solving methods.

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