Trying to figure out what satisfies a few aspects of IEC 62304

#1
Hello, new to the forum here.

My company is building a medical device and I was hired on to help establish the software verification and validation. My company does not have a lot of procedure in place so I've been trying to get a thorough understanding of what needs to be done to meet all aspects of IEC 62304:2006.

My questions:

5.1.3 a)As inputs for software development, system requirements shall be referenced in the software development plan by the Manufacturer.
Does this mean I have to list out the requirements? Or merely point to a system requirements document?
5.1.3 b)Manufacturer shall include or reference in the software development plan procedures for coordinating the software software development and the design and development validation necessary to satisfy 4.1.
I'm really not sure what this means

Thanks in advance.
 
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yodon

Staff member
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#2
Hello, new to the forum here.
Welcome!

5.1.3 a)As inputs for software development, system requirements shall be referenced in the software development plan by the Manufacturer.
Does this mean I have to list out the requirements? Or merely point to a system requirements document?
The intent is to establish the linkage between the system requirements and the software requirements. You need to know if your software is complete (in the overall system context). You also need to know what the impact is if either 'side' changes.

5.1.3 b)Manufacturer shall include or reference in the software development plan procedures for coordinating the software development and the design and development validation necessary to satisfy 4.1.
I'm really not sure what this means
Nothing too deep here: how do you coordinate the software development; e.g., between groups doing the software development, between groups developing different software items, between software development and systems engineering, etc.

Then, what validation is required to satisfy 4.1, Quality Management System (...demonstrate that the software... consistently meets customer requirements and applicable regulatory requirements). Compliance with 62304 supports such assertions. By complying with 62304, you demonstrate that you have properly established requirements (including those from risk analysis) and that the software is aligned with the systems-level requirements. The software is designed and tested to an appropriate level (by class). The software is under control and changes are properly managed.
 

MrTetris

Involved In Discussions
#3
Hello, new to the forum here.

My company is building a medical device and I was hired on to help establish the software verification and validation. My company does not have a lot of procedure in place so I've been trying to get a thorough understanding of what needs to be done to meet all aspects of IEC 62304:2006.

My questions:

5.1.3 a)As inputs for software development, system requirements shall be referenced in the software development plan by the Manufacturer.
Does this mean I have to list out the requirements? Or merely point to a system requirements document?
5.1.3 b)Manufacturer shall include or reference in the software development plan procedures for coordinating the software software development and the design and development validation necessary to satisfy 4.1.
I'm really not sure what this means

Thanks in advance.
Hello,
Let me try to answer your questions.

5.1.3 a) The focus here should be on showing that system requirements (and not only sw req) should be taken into consideration in the software development plan. It is up to you to list system requirements in the SDP or point to a system requirements document (the latter is probably the best - read: "less burdensome" - solution). Anyway, it is important to link specific system requirements to specific sw requirements (a generic doc-doc link will not be probably accepted by an auditor).

5.1.3 b) has changed in the 2015 version:
In the software development plan, the MANUFACTURER shall include or reference procedures for coordinating the software development with the system development necessary to satisfy 4.1 (such as system integration, verification, and validation).
Much more clear now, isn't? :)
 
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