Medical Device Regulation
Is the product "software" according to the definition?
This is the definition of software
ISO13485:2016<br />
Medical devices – Quality management systems
Requirements for regulatory purposes
ISO14971:2019<br />
Medical devices — Application of risk management to medical devices
Does your Medical Device include a software?<br />
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IEC-62304: 2006 +A1:2015<br />
Medical device software — Software life cycle processes
Does your software development include Design and development of information for users ?<br />
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ISO/ IEC/IEEE 26514:2022
Systems and software engineering — Design and development of information for users
Does your device include medical electrical equipment?<br />
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IEC60601
Medical electrical equipment
5. Is the software a Medical Device Software (MDSW) according to the definition of this guidance?<br />
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