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Infographic: Software a Medical Device

Infographic: Software as a Medical Device

Anne Sophie Dil

Co-founder of NAALA

Published on 6 July 2021

By: Anne Sophie Dil  – Co-founder of NAALA

Published on 6 July, 2021

Innovation is everywhere, including in the medical world. Increasingly, software is being used in e.g. diagnosis, treatment, prognosis and relief of an illness or disability. As a result, software is increasingly classified as a medical device. This means that medical device rules must be applied to new technologies, such as artificial intelligence, virtual/augmented reality and other types of software applications. How to determine whether software is a medical device under the European Medical Devices Regulation (MDR)? This requires going through 5 simple questions.

Infographic Software as a Medical Device
Infographic Software as a Medical Device

Medical software may therefore be subject to medical device legislation. In addition, software applications (in general) have to deal with data storage and exchange, so information security and privacy standards and laws also have an impact. In order to develop a safe and high-quality (software) product, the entire regulatory framework must be taken into account.

Do you want to know if your software is a medical device? Would you like to know what the regulatory framework means for you, or how you can implement is practically and efficiently? Feel free to contact us!

Source: MDCG 2019-11

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only. Changes in legal or regulatory requirements may occur at short notice, which we cannot reflect on a daily basis. 

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