IEC 62304 is the medical equivalent to DO-178 and ISO 26262. Class 3 is the strictest safety class within the relevant standard, where death or serious injury may occur. (Similar to DO-178 DAL A: Serious Loss of Life, and/or aircraft)
The SC standard begin created should be created to be able to meet the goals and objectives of IEC 62304.
Comment 1 Erik Noreke 2016-09-20 13:07:27 PDT
Setting QA contact to non-member SCAP mailing list.
Comment 2 Erik Noreke 2016-09-26 07:41:29 PDT
Assigning to Illya to suggest wording and document structure per call 2016-09-26
Created attachment 4021 [details]
A rule or guideline suggested layout to summarise relevant SC processes covered by a rule or guideline
Here is my idea how to present a requirement or guideline 'section'. Since there will a lot of text I wanted a way for a reader to be able to quickly glance at the section and determine how relevant it is them.
I have attached a Microsoft Word document show the example:
Daniel Herring 2016-09-13 06:09:54 PDT
IEC 62304 is the medical equivalent to DO-178 and ISO 26262. Class 3 is the strictest safety class within the relevant standard, where death or serious injury may occur. (Similar to DO-178 DAL A: Serious Loss of Life, and/or aircraft)
The SC standard begin created should be created to be able to meet the goals and objectives of IEC 62304.
Comment 1 Erik Noreke 2016-09-20 13:07:27 PDT
Setting QA contact to non-member SCAP mailing list.
Comment 2 Erik Noreke 2016-09-26 07:41:29 PDT
Assigning to Illya to suggest wording and document structure per call 2016-09-26
Comment 3 illya@codeplay.com 2016-10-10 04:08:17 PDT
Created attachment 4021 [details] A rule or guideline suggested layout to summarise relevant SC processes covered by a rule or guideline
Here is my idea how to present a requirement or guideline 'section'. Since there will a lot of text I wanted a way for a reader to be able to quickly glance at the section and determine how relevant it is them.
I have attached a Microsoft Word document show the example:
ExampleSectionBriefTable-1.docx