2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability 2007
DOI: 10.1109/hcmdss-mdpnp.2007.6
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FDA: Between Process and Product Evaluation

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Cited by 6 publications
(8 citation statements)
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“…In terms of software development[, the FDA approach does not favour any specific software development model.] [9] In other words, it leaves the choice of the approach to be used in developing the software to software producers themselves. This supports the fact that some organizations have there own policies, standards and development approaches [that] must be followed.…”
Section: Process Oriented Standards and Certificationmentioning
confidence: 99%
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“…In terms of software development[, the FDA approach does not favour any specific software development model.] [9] In other words, it leaves the choice of the approach to be used in developing the software to software producers themselves. This supports the fact that some organizations have there own policies, standards and development approaches [that] must be followed.…”
Section: Process Oriented Standards and Certificationmentioning
confidence: 99%
“…(From [9,10]: ) Having such a measurement framework defined will decrease [the level of] subjectivity in the evaluation activity. The FDA approach lacks such a measurement framework.…”
Section: Measurement and Product/process Modellingmentioning
confidence: 99%
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