I think @smithshah sums it up well above. Design Verification Inputs=Outputs Design Validation Outputs=user needs and intended use Design Verification is- did you design the device correctly? Does y...

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 intended use. I really don't think there is any room ...

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 scope creep in my opinion. I agree with the comments a...

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 deal with a team member's vacation, or absence. As ...

The PMBOK guide provides an overview of the Project Integration Management processes. I. Project charter as mentioned above II. Project Management Plan the process of performing the work defined in th...

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 Stakeholders had signed off on the scope of the proj...

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 spend as much time and money on experiments that migh...

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 Simulation, the importance of logging these incid...

In lecture we learned the steps of Validation; I. Determine what to validate (IQ,OQ, PQ), II. Write a validation protocol III. Run the protocol, collect the data IV. Analyze the data V. Make improveme...

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

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 a femoral implant? IQ- Femoral molding equipment ...

I agree with @asimbana that ISO provides more flexibility with their definition "processes for production and service provision where the resulting output cannot be verified by subsequent monitoring o...

We learned this week that Risk Analysis for a process is conducted when the process is first designed, changes are made to process, and when a Corrective and Preventative Action (CAPA) is filed on the...

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 the devices. So the company will come and meet with...

The Project Planning Phase is extremely important and crucial to the project's success. Going off what @ks629 mentioned, its necessary during the planning phase to mitigate risk and to have contingenc...