Verbal contracts can be followed through ensuring that the agreement is as clearly defined as possible to attempt to prevent the opposite party from identifying and exploiting loopholes. When these ve...

Although a scenario like this may appear to be too restrictive, I believe that it is best to maintain these strict practices to ensure that ethics are not being compromised. As mentioned by others, th...

The days of giving gifts like the "old days" are in the past for most companies today. The company that I am currently working at actually assigns a specific training relating to this exact topic and ...

Currently, I work within a matrix organization in which I work within a certain department and am involved within different project groups. This style of organization is a good fit for me as it allows...

Upper management typically includes executives whereas middle management can be managers over particular departments or teams. In upper management, the executives typically evaluate decisions from a b...

My team has had two meetings so far virtually since it is difficult to meet in-person due to each person having different class schedules as well as working during the day. As of now, we have complete...

Risk management should be a team effort and should thus be equally as important across all functional areas. Although Quality may be the department that actually develops the documentation pertaining ...

It is important to understand both. In order for a device to be successful, the rewards have to be evident to appeal to the market. Although it can be tempting for companies to be solely focused on th...

Risk assessments are crucial for medical devices as they lay out potential risks that can occur in the device. A risk assessment allows a team to see the different risks possible and find a way to mit...

Companies should have a high sense of corporate responsibility, particularly within the medical device and pharmaceutical industry due to their products having a direct impact on patient health. The i...

Within a design review meeting, it is important to ensure that each department involved in the project should be represented at the meeting. This may include the project lead as well as the quality le...

Minutes for meetings are crucial as they allow for team members to be aligned on what was discussed throughout the meeting. This can be helpful in ensuring that team members are aware of what tasks ne...

Different departments within a medical device company have a hand in working with design controls. A quality assurance department may be focused on developing the inputs and outputs for the device, th...

When revising design controls it would be important to observe whether they follow the desired inputs and outputs for the device. From there, the first and most important step to implement to keep ope...

A factor to consider when developing a test method and protocol is repeatability. It is essential that the test can be performed at a different instance with a different operator. For example, in my c...