One factor to take into consideration would be the risk associated with losing your only supplier. If you opt to more suppliers, you reduce the risk associated with procurement, but increase the risk of effectiveness complaints. Therefore, having fewer suppliers…   Read more»

It’s never truly safe to use any method that causes an increase to risk or cost. After completing a risk analysis, duration compression should only be used if there’s no safer option. In the case of an emergency authorization from…   Read more»

In order to prevent scope creep from happening, the scope process should begin as soon as possible. During initiation, all information of project history should be compiled when determining what the product can or can’t do. The Work Breakdown Structure…   Read more»

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 equipment or other processes being done out…   Read more»

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 effectiveness, and the results to prove its safety and…   Read more»

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 career, every process in the project…   Read more»

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 previous successful projects. Those can be used…   Read more»

Hi everyone. My name is Brandon Klavansky, and I’m a BME MS student at NJIT. I’m looking forward to connecting.
 
http://www.linkedin.com/in/brandon-klavansky-b66479208

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 email server in order to protect sensitive information.  Microsoft Teams…   Read more»

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 costly, the time given is valuable…   Read more»

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 scenario described above, where they discovered a…   Read more»

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 required more feasibility data, and…   Read more»

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 what the company claims for either…   Read more»

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 this case, we’d…   Read more»

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 they excluded a large amount of customers. In…   Read more»

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 know how projects…   Read more»

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 hypothesis. The Test Method Validation is to predict the…   Read more»

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 should be a plan included to…   Read more»

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 components approved by them. I…   Read more»

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…   Read more»