I have experience as a Quality Engineer. One of my tasks was to manage the equipment maintenance schedule and order calibration services. During production of the devices, my team and I would catch eq...

I think in order create an innovative design that passes all regulatory compliance, it should have an effective Validation Plan. The validation method is required to test the device's safety and effec...

Although I worked for a company before with a Team, I don't have experience Initiating and Managing a Project. I think that as an Engineer becomes more experienced with managing many projects in their...

In order to reduce the time and money needed for a project while also increasing the chance for a successful product is to gather up all previous meeting minutes, schedules, and procedures for previou...

Hi everyone. My name is Brandon Klavansky, and I'm a BME MS student at NJIT. I'm looking forward to connecting. Here's my LinkedIn:

I think that email communication is used for official information that includes meeting invites, task delegations, and announcements from the manager. Most companies will use a VPN with a private emai...

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...