Hello,
this is my first message and, first of all, I would like to congratulate with the users and administrators who spend their time answering questions. I find this forum very useful especially for the ones, like me, who are entering the field of medical devices.
I am trying to map FDA 21 CFR 820.30 requirements with an incremental and iterative life cycle (before doing the same with IEC 62304). I found some food for thought in several threads but there is a couple of simple questions that I cannot answer yet.
1) Do Design Inputs need to be approved before Design Output are produced? If yes, is there any place where such a constraint is clearly stated?
2) If the answer is yes, and we adopt an iterative and incremental software development life cycle, then does it imply that, from the second iteration onward, every single activity must be carried out in terms of design change?
For example, let's consider two iterations for a generic project. During the first iteration we specify a requirement R1, the overall architecture, a component C1 and its corresponding code. Assuming that the answer is yes, then before working on the architecture we need to approve R1, which becomes the Design Input, and the other elements are collected as Design Outputs (please, correct me if I am wrong).
Now, during the second iteration we want to add a new requirement R2 and develop the corresponding software unit C2 (with its code). Does it mean that such an improvement, as well as any further improvement of subsequent iterations, must be carried out within a change request as we need to update the Design Inputs and Outputs generated in the first iteration?
Thanks a lot.
this is my first message and, first of all, I would like to congratulate with the users and administrators who spend their time answering questions. I find this forum very useful especially for the ones, like me, who are entering the field of medical devices.
I am trying to map FDA 21 CFR 820.30 requirements with an incremental and iterative life cycle (before doing the same with IEC 62304). I found some food for thought in several threads but there is a couple of simple questions that I cannot answer yet.
1) Do Design Inputs need to be approved before Design Output are produced? If yes, is there any place where such a constraint is clearly stated?
2) If the answer is yes, and we adopt an iterative and incremental software development life cycle, then does it imply that, from the second iteration onward, every single activity must be carried out in terms of design change?
For example, let's consider two iterations for a generic project. During the first iteration we specify a requirement R1, the overall architecture, a component C1 and its corresponding code. Assuming that the answer is yes, then before working on the architecture we need to approve R1, which becomes the Design Input, and the other elements are collected as Design Outputs (please, correct me if I am wrong).
Now, during the second iteration we want to add a new requirement R2 and develop the corresponding software unit C2 (with its code). Does it mean that such an improvement, as well as any further improvement of subsequent iterations, must be carried out within a change request as we need to update the Design Inputs and Outputs generated in the first iteration?
Thanks a lot.