26. 06. 2024

Medical Device Regulation ISO Standards

What Are Medical Device Regulation ISO Standards?

If you are an expert in the regulatory/quality field (scroll for a summary of ISO Standards), then you will know that Medical Device Regulation ISO standards developed by the International Organization for Standardization (ISO), an independent, non-governmental international organization based in Geneva, Switzerland. ISO was founded on February 23, 1947. They are international standards developed to assist in improving medical device quality, efficiency, and perhaps most importantly; safety.



Why Were The ISO Standards Developed?

One of the most important reasons for the development of Medical Device Regulation ISO standards was to help ensure patient safety, by ensuring regulatory compliance, reducing risks; with risk management, quality assurance.


Moreover, ISO Standards are deemed as important by Medical Device manufacturers because they are often referenced by notified bodies throughout compliance assessments, and they help guide manufacturers towards compliance, and producing high quality devices.


How Do Manufacturers Become ISO Certified?

In order to become ISO certified, manufacturers are audited by an independent certification body. Upon successful completion of the audit, manufacturers are awarded with an ISO certification.



Where Can I View Major Medical Device Regulation ISO?

They are critical to remaining compliant with regulatory requirements. This is because many ISO are recognized by regulatory bodies such as the FDA, or have been harmonized with Europe regulations.


This document, by Greenlight Guru, does not include every ISO standard, however, it does include some of the most universal, and important standards for producing safe and impactful medical devices.






In conclusion, Medical Device Regulation ISO were initially developed to ensure safety of patients, and improve Medical Device quality and efficacy. However, they have since been recognized by notified bodies, and manufacturers to become critical to our industry.


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