Hello, everyone,
I would like to understand the connection between chapter 14 and IEC 62304 in connection with CB testing
Is it true that the testing laboratory does not review the software documentation if chapter 14 is not applicable? (If Software does not affect Basic Safety or Essential Performance)
The software is documented anyway, but Chapter 14 is not applicable. But I thought that the IEC 62304 was part of the CB scheme?
Thank you.
I would like to understand the connection between chapter 14 and IEC 62304 in connection with CB testing
Is it true that the testing laboratory does not review the software documentation if chapter 14 is not applicable? (If Software does not affect Basic Safety or Essential Performance)
The software is documented anyway, but Chapter 14 is not applicable. But I thought that the IEC 62304 was part of the CB scheme?
Thank you.