Hello All,
I have been introduced to a product under development. It is a Class C Medical device as per 62304.
The team has already performed some verification (System tests). Now, the verification strategy consists of a combination of the following testing levels:
What this resulted in, is that some software requirements are only tested by code review or unit testing and have no explicit system tests associated.
Is this considered okay, or does each and every software requirement need to be tested (not including code review and unit tests)
Looking forward to the answers. TIA
I have been introduced to a product under development. It is a Class C Medical device as per 62304.
The team has already performed some verification (System tests). Now, the verification strategy consists of a combination of the following testing levels:
- Code review
- Unit
- Integration
- Software system
Is this considered okay, or does each and every software requirement need to be tested (not including code review and unit tests)
Looking forward to the answers. TIA