Software in Medical Devices, a blog by MD101 Consulting

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Monday 21 January 2013

Class A, B and C. Is it possible to reduce the documentation of detailed design of software medical devices?

In the last two posts, we've seen what a software unit is, and when to do software detailed design, according to IEC 62304 and FDA Guidances.

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Friday 18 January 2013

Class A, B and C. When to do detailed design of software medical devices?

In my last post, I explained what criteria should be taken to define the level of details of software units in a software design. This activity is not mandatory for all levels of risk of software in medical devices, though, according to IEC 62304.

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Friday 11 January 2013

What is a Software Unit?

IEC 62304 requires to split architecture of class C (mission critical) software into software items and software units. Software units are software items that can't be split into sub-items, according to the standard. Okay. But how to decide that an item can't be split into sub-items, and is a unit?

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