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Software as a Medical Device

Software within the healthcare industry is exploding with innovation so much so that regulation is only now starting to catch up!, making software key to a medical device revolution. Software is now incorporated within many medical devices including smartphones. This means that such software and applications must abide by the relevant EU legislation and must obtain a CE mark before placing on the market.

Software as a Medical device is a piece of software which is intended to be used for one or more medical purposes. Software that performs these purposes without being part of the medical device is known as Stand Alone Software classified as an “Active Medical Device”.

One must also consider the case in which the software is incorporated into the medical device, driving and/or influencing its behaviour. In this case, the software shall fall into the same classification as the device itself.

In some cases Software may be a borderline medical devices which can make it difficult to determine its classification. At Advena, we have the necessary experience to determine the correct classification of your software based on its description and intended use, as well as build the EU compliant technical documentation which you will require to obtain the CE mark.

For further information on how we can help get your software on to the EU market, please contact us on

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