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Standalone medical device software: The evolving regulatory framework.

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Title: Standalone medical device software: The evolving regulatory framework.
Authors: McCarthy, Avril D.1,2,3 (AUTHOR) avril.mccarthy@sth.nhs.uk, Lawford, Patricia V.4,5 (AUTHOR)
Source: Journal of Medical Engineering & Technology. Oct2015, Vol. 39 Issue 7, p441-447. 7p.
Subjects: Computer software laws, Medical equipment laws, Computer software, International relations, New product development laws, Government regulation, Equipment & supplies
Geographic Terms: Europe
Abstract: The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software—sometimes referred to as ‘software as a medical device’. To aid the reader’s comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice. [ABSTRACT FROM PUBLISHER]
Copyright of Journal of Medical Engineering & Technology is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Engineering Source
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  Data: <searchLink fieldCode="DE" term="%22Computer+software+laws%22">Computer software laws</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+equipment+laws%22">Medical equipment laws</searchLink><br /><searchLink fieldCode="DE" term="%22Computer+software%22">Computer software</searchLink><br /><searchLink fieldCode="DE" term="%22International+relations%22">International relations</searchLink><br /><searchLink fieldCode="DE" term="%22New+product+development+laws%22">New product development laws</searchLink><br /><searchLink fieldCode="DE" term="%22Government+regulation%22">Government regulation</searchLink><br /><searchLink fieldCode="DE" term="%22Equipment+%26+supplies%22">Equipment & supplies</searchLink>
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  Data: The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software—sometimes referred to as ‘software as a medical device’. To aid the reader’s comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice. [ABSTRACT FROM PUBLISHER]
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  Data: <i>Copyright of Journal of Medical Engineering & Technology is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.3109/03091902.2015.1088087
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      – Code: eng
        Text: English
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        PageCount: 7
        StartPage: 441
    Subjects:
      – SubjectFull: Computer software laws
        Type: general
      – SubjectFull: Medical equipment laws
        Type: general
      – SubjectFull: Computer software
        Type: general
      – SubjectFull: International relations
        Type: general
      – SubjectFull: New product development laws
        Type: general
      – SubjectFull: Government regulation
        Type: general
      – SubjectFull: Equipment & supplies
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      – SubjectFull: Europe
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              M: 10
              Text: Oct2015
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              Y: 2015
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