For starters, I believe it is important to first verify that every individual at the meeting is on the same page about what the project is and a basic idea of what it will entail. Following this, as a...

In terms of the magnitude of company liabilities for risks associated with misuse of a product by a user, I believe is dependent on the situation at hand. For starters, I believe it is important that ...

For starters, I believe the inclusion of the non-descriptive statement of “As Far As Possible” is due to the fact that risks can vary greatly depending on the product. For example, any medical product...

I believe the advantage of separating the two documents is that it helps break down the project and makes it easier to conceptualize. Since the DID is the first document following the PDF and DDP that...

In terms of outsourcing the production of a biomedical device, I believe the type of product being made has a major influence on whether this could pose potential pros and cons. For example, if the pr...

Personally, I believe the ultimate purpose of design controls is to make the project team think thoroughly about every minor to substantial aspect of the project. Through such an in-depth analysis, th...

The sources that help determine design inputs can come from a variety of different areas such as customer feedback or intended purpose of product. For example, if feedback gathered from target consume...

Verification is an important aspect of design controls that puts the claims and specifications defined by the project team to the test. In a general overview, verification helps assess a product meets...

In my opinion, I believe the importance and usefulness of standardized design controls is that it necessitates the project team to question every detail of the project as well as document every aspect...

For starters, I believe a double blind study is definitely better for clinical trials that involve the testing of things like a new medicine or pill. The reason for this is that it removes any additio...

In my opinion, I believe it is very important for patients to be given the decision to determine whether data or samples pertaining to them can be used for research or other purposes. For starters, th...

As mentioned by Dr. Simon, a major factor involved in high level clinical tests is the ability to remove any bias that could impact the results of a test. In the case posed in the question here, the b...

In my opinion, I believe that marketing can in some cases be manipulative and can coerce someone into buying something that they do not need. In a scenario such as this, I believe this is a form of ma...

In my opinion, two of the most powerful advertisements that I have seen are both by the company Apple and aired before I was born. Nonetheless, I believe both advertisements are quite iconic and memor...

With the continuously increasing forms of entertainment platforms that one can choose from, it has become more crucial for companies to engage the attention of viewers and assure that their form of ad...