![]() | This article is rated Stub-class on Wikipedia's
content assessment scale. It is of interest to the following WikiProjects: | |||||||||||||||||||||||
|
What events led to the IEC 62304 standard being developed? (The Therac-25 article says the IEC 62304 standard was created "In response to incidents like those associated with Therac-25". What incidents is that alluding to?)
Are there any previous standards for medical software that the IEC 62304 obsoletes or complements? -- DavidCary ( talk) 17:32, 17 August 2015 (UTC)
The part where it says which documentation is needed is not accurate enough. It looks like class B and C need exactly the same. It is better explained on the following blog. https://www.mddionline.com/developing-medical-device-software-iec-62304
--pinar 09:03, 11 September 2017 (UTC) — Preceding unsigned comment added by Jlpinar83 ( talk • contribs)
![]() | This article is rated Stub-class on Wikipedia's
content assessment scale. It is of interest to the following WikiProjects: | |||||||||||||||||||||||
|
What events led to the IEC 62304 standard being developed? (The Therac-25 article says the IEC 62304 standard was created "In response to incidents like those associated with Therac-25". What incidents is that alluding to?)
Are there any previous standards for medical software that the IEC 62304 obsoletes or complements? -- DavidCary ( talk) 17:32, 17 August 2015 (UTC)
The part where it says which documentation is needed is not accurate enough. It looks like class B and C need exactly the same. It is better explained on the following blog. https://www.mddionline.com/developing-medical-device-software-iec-62304
--pinar 09:03, 11 September 2017 (UTC) — Preceding unsigned comment added by Jlpinar83 ( talk • contribs)