Something that many companies will do during the planning phase is to do experimental and characterization testing. They do not require any acceptance criteria or sample size requirements that verific...

@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 verification testing needed for a product in the early st...

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 sustaining projects, the project has been launched and...

This topic may be more for those who have industry experience. For those who have experienced the design process and have seen a project go from charter to verification or launch, what has happened wh...

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 specifications. If you scrutinize the inputs and re...

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 their decisions and the decisions their team is w...

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 functional team. The past year has drawn up an issue with ...

Although I agree with everyone that all phases are important, I believe the phase (can be different names) right before verification and validation are the most crucial for project succession. Yes, go...

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 upload a new revision of each of the documents to expla...

To further strengthen the argument for a matrix based organization, I have personal experience in the matrix based organization style. We even have a training based upon this to have everyone understa...

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. This can be done in multiple ways to save money and t...

Posted by: @mark-abdelshahed So it really depends on the product. Most of the products functional testing are per ISO and ASTM standards, which are international standards that most of the internatio...

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 submitting the request to refer to the latest version ...

Posted by: @ad487 From a management perspective, both from a small product management team within a global corporation or upper-level management, how would they be affected by situations like these? ...

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 of their device. Class II devices have a large subs...