Software as a medical device

Software as a medical device

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Software as a medical device
Software as a medical device
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Unrivaled expertise from an EU Notified Body and UK Approved Body for software medical devices

As a manufacturer of software as a medical device, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market; for the EU, these are outlined in the Medical Device Regulation (MDR) (EU) 2017/745 and, for the UK, the UK Medical Devices Regulations (UK MDR) 2002.






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