K
keroppilee
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.
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.