I think it depends on what you mean by Slack Time. Unexpected delays can happen and extra time should be given for cases such as failure in Validation or Verification phases. Although it's initially c...

I agree that feasibility studies will improve the chances of success in the Design Control process and help a project lifetime. Innovative projects are often higher in risk, an can result in the scena...

Using ES, EF, LS, and LF is very helpful for planning for any contingencies. Many factors can cause delay in a schedule such as not thoroughly examining Project or Design Inputs. A device may have req...

I agree with @gdecarvalho22 above that the FDA indirectly approves the tests as long as the final design and design process shows to comply with FDA standards. If the test parameters are not within wh...

Hypothetically, if the bottles are meant to be stored in 37C due to its contents, then we can't change the testing parameters. The bottles' labels must be able to stay adhered to the bottle at 37C. In...

When Verification tests fail, I think that the best approach is to first evaluate whether the model still fills the need of the customer. The testing parameters could've been set incorrectly because t...

In my personal experience, I had to jump into a role working with a team in a functional organization, not yet knowing how organizations worked and the meaning of the tasks I was doing. Know that I kn...

The Design verification and Validation test the design of your product. In an experiment, there are always statistical analysis to determine the significance of the results to prove or disprove the hy...

Determining the spec with tolerances is the most important part in the effectiveness of the design. It really depends on the application and market in my opinion. If it is an orthopedic implant, there...

I agree that those devices may need to be regulated by all three sub-agencies. If the design contains any drug or biologic components, the other agencies might come after us if we don't get those comp...

A 510(k) is used for class II devices which rely on a predicate device for its design and purpose. If the device is the same category as a long existing device, this form can use the older device as a...

In order to handle conflicts effectively, we should have open communication from the beginning of the project. Managers need to share what is expected of their employees before the start of the projec...

If the cause of failure was with the device design, then verification will take longer, and the timeline should be anticipated to be pushed back. As a project manager, I would confer with the Engineer...

I think where the value goes depends case-by-case. Those decisions are often made before creating a project, and involves outlining the strategy and analyzing the market and economy. If the market and...

Incorporating newer technology will affect the project's lifetime. Therefore, to determine the effect that newer technology will have, it should first be determined whether the new technology will hel...