Something that many companies will do during the planning phase is to do experimental and characterization testing. They do not require any acceptance...

@sanam This may actually mislead people who read this. Design verification is an end goal where it is good to keep in mind to think about the verif...

The risks I've personally seen deals with both sustaining of products as well as seeing a remediation for a product has failed in the field. For su...

I think one highly important area of learning that this simulation was able to bring about was to take a step back and look at the design inputs and s...

Adding to @nr473 who summed up the business area that a project manager must be very well, I also believe the project manager needs to be confident in...

I currently work in a matrix based organization and I think it works great once you have enough talent and personnel to work within the cross function...

Although I agree with everyone that all phases are important, I believe the phase (can be different names) right before verification and validation ar...

In my experience, that is dependent on the project that is being worked on. If its a minor change, a team can add a rationale, justification, or uploa...

To further strengthen the argument for a matrix based organization, I have personal experience in the matrix based organization style. We even have a ...

I wouldn't say a project should be cutting corners, but rather use previously reliable data to prove that the new product is not a new worst case. Thi...

This sums a large amount of the verification activities completed for the project. There are also other areas of consideration where regulatory bodies...

If you received the design change request that was based on the current version, it would be best to have rejected the request and ask the person subm...

For a small product management team within a global corporation, it depends on how management values their employees. I know many large industries fur...

This may entirely rely on the industry that the class II device is within and may vary on how well the industry is able to prove efficacy and safety o...