I think @smithshah sums it up well above. Design Verification Inputs=Outputs Design Validation Outputs=user needs and intended use Design Verifica...

Hopefully if the user needs are not met as @hc255 mentions above, they would go back to the spec and make sure the output meets the user needs and int...

So for this particular example to plan on selling a medical device in US and then decide in executing phase to sell in Japan, this would be a big scop...

If you're in the Executing Phase it is the Project Manager's responsibility to make sure that the team is performing their tasks on schedule and to de...

The PMBOK guide provides an overview of the Project Integration Management processes. I. Project charter as mentioned above II. Project Management Pla...

I also think its important to identify what the new PM considers the error in the Scope to be. I agree with the above posts, but I think if the key St...

As a means to save time and money and still hit the product launch, I agree with @cdj24 to get as much research done as possible so that you don't spe...

I agree with what most of said that determining the main cause of the equipment failure and to add to the discussion, I would say based on this week's...

As @merzkrashed mentions the FDA "results of a process cannot be FULLY verified by subsequent inspection and test" and ISO "processes for production a...

Since the previous devices’ IQ, OQ, and PQs have been explained in great detail, what would the IQ, OQ and PQ look like for other devices? For example...

I agree with @asimbana that ISO provides more flexibility with their definition "processes for production and service provision where the resulting ou...

I work at a non-profit hospital so for our more robust medical devices that we are unable to develop in-house, we use outside contractors to develop t...

The Project Planning Phase is extremely important and crucial to the project's success. Going off what @ks629 mentioned, its necessary during the plan...