Medical Devices – ISO 13485

ISO 13485:2016 – Medical Devices – The Latest Revision

February 12th, 2016|Medical Devices - ISO 13485|

ISO 13485:2016 - Medical Devices  Quality Management Systems - Requirements for Regulatory Purposes The international Medical Devices Quality Management Systems (QMS) ISO 13485 standard was revised and published in March 2016, giving us ISO 13485:2016. Why update the standard? [...]

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ISO 13485 : 2015 – the next revision

August 1st, 2014|Medical Devices - ISO 13485|

Voting has now closed on the next revision to ISO 13485 "Medical devices — Quality management systems — Requirements for regulatory purposes". All comments received by the ISO/TC 210 working group (the ISO group that is revising the standard), the comments will now be reviewed [...]

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Should we expect unannounced ISO 13485 audits in the future?

May 15th, 2014|Medical Devices - ISO 13485|

There are big changes coming up in the regulation of European medical devices, with anyone who sells medical devices in the European markets likely to be affected. Ineffective processes and regulations are likely to be weeded out, with changes likely to be applied across the [...]

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Ageing population will cause greater need for blood pressure monitors

September 16th, 2013|Medical Devices - ISO 13485|

Sales volumes of blood pressure monitors look set to rise across the world in coming years as the population ages, isuppli.com reports. As populations across the world become healthier – and therefore start living longer – the need to monitor blood pressure is only set to rise. [...]

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