New ISO Standards for Medical Devices

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Setting international standards when it comes to devices, procedures and regulations in the medical sector is of critical importance, helping medical professionals and institute managers keep patients as safe as possible throughout the entirety of their stay.

Keeping the various standards up to date and relevant, as well as simple to find and follow is as critical. At ISO, the independent NGO that brings together experts who share knowledge and develop relevant international standards, new standards are regularly introduced either to fill a need or to update or supplement existing standards as new information comes to light.

The most recent new standards include the following:

ISO20417 Medical devices – Information to be supplied by the manufacturer

This simplifies the process of meeting product information regulations by providing common generic requirements that are consistent across all devices in all geographical locations. The new standard will serve as a central source, thus reducing the likelihood of duplication and leaving specific product standards to focus more precisely on their unique requirements.

Technical report ISO/TR 20416 Medical devices – Post-market surveillance for manufacturers

This provides guidance on effectively monitoring the safety, performance and usability of the device in everyday use. This is essential to be able to spot any undesirable effects quickly, while also highlighting areas for improvement in safety, performance and usability.

Wil Vargas, Committee Manager of the ISO technical committee which developed the new standards, says both new standards are designed to help manufacturers improve their products in line with legal and regulatory frameworks, and to help end users apply the standards measurements when the devices are in use.

Vargas says, “These two documents, therefore, not only embody international best practice but help manufacturers adhere to national and regional regulations and recommendations such as those from the International Medical Device Regulators Forum, EU directives on medical devices and many other International Standards, including ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes.”

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New ISO Standards for Medical Devices

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