Upholding NDAs can build a contractor's reputation as trustworthy, and help them build relationships with companies. A good contract should be made so that sensitive information should only be shared ...

Before signing an NDA, one must read through the entirety of the document and understand every part of it. If there is any discrepancy, all questions must be answered and understood. You should know t...

Written and Verbal contracts are both effective, however, for different purposes. A written contract is much more commonly used because its written agreement can be kept recorded for extended periods ...

I think a solution to this problem could be creating surveys on staff satisfaction with the managers, as well as creating meetings to discuss and align team values and goals. When the manager hears ou...

I think each member in a team should be a good fit with the role they take in a team. Relationships can be a challenge, so there should be a balance between have good relationships and knowledge. If s...

During the Covid pandemic, communication between individuals and teams were very impacted. For functional organizations, a clear, hierarchical system must be maintained. Virtual work disrupted this be...

The FMEA is most valuable when determining the risks on a device. It can detect additional failure modes that add to the list of possible risks. It determines the risk something can go wrong, and unde...

I agree that risk avoidance is the best way to deal with any level of risk, especially in manufacturing. However, mitigation tools and acceptance criteria are also important to use in risk avoidance. ...

To determine the acceptable level of risk, it's important to follow the Risk Management Process. First, do a Risk Analysis and Estimation to list the possible risks of the device for the analysis, and...

Hi elm33, After this week's lecture, I feel a lot safer knowing about Verification/Validation. These steps are there to catch flaws early on, and if the device will perform its intended function. Veri...

Verification tests whether design outputs match design inputs. Validation tests whether design outputs satisfies user needs. In my previous job as a Quality Engineer, I took part in the verification t...

One way to improve design transfer is to implement the use of CAD drawings so manufacturing can better understand how to make the product. This can include a Bill of Materials, and what to include and...

Companies will have Design Input and Design Specification documents in their DHF. They might not have a Design output because the Design specification might already outline the outputs. In some cases,...

Software Validation has many advantages. Software validation ensures that the device meets regulatory standards. This makes for quicker regulatory approval, and market access. If the software is used...

Validation is very important to ensure that the costumer needs are met. This may involve using Human Clinical Trials. This is a step further that Design Verification, which only checks if the Design s...