Personally, I believe that the entire process can be made simpler if the guidelines are revised so that the healthcare professional cannot be given gifts or be taken out for meals for the duration tha...

One of the most important topics that should be covered is the scope of the work that the consultant is being hired to do. Once the scope is clearly defined then the company can determine a reasonable...

As mentioned in the above posts, a NDA cannot really prevent anyone from disclosing information about the business or other party. It is more so used as evidence or proof that the receiving party sign...

As mentioned in the above comments, communication is important for the person making the decision to be informed on all the different aspects of the topic before they decide anything. I believe that t...

The components of a Design and Development Plan (DDP) are defined in ISO 13485. Two main aspects of the DDP are drafting the overall plan and objectives of the project and to approve it using design c...

Both Gantt charts and Network diagrams aid in presenting project schedules and tasks in a graphical manner. Gantt charts tend to be a bar chart that shows the project schedule while Network diagrams a...

Medical devices are classified based on their risk level. The categories are low risk, low to moderate risk, moderate to high risk, and high risk. Multiple factors affect medical device risk classific...

A tool used to mitigate risks is the fish bone diagram. These diagrams are a visual way to look at cause and effect. There are essentially 4 main steps to using a fish bone diagram. 1. Write the main ...

As mentioned by @ms2768, the scalpel example from the lecture depicts what risks are acceptable and which ones must be mitigated. I believe that a simple way to differentiate the risks are to ask whet...

As everyone else has said, while both processes are testing the product, they each test different aspects. Verification directly tests the product's specifications, for example, the color or size of t...

My favorite components are the design inputs, verification, and validation. Design inputs are needed in order for the team to know what the consumer needs are and what the details of the device design...

I'm certain that projects start out with more inputs based on specifications and customer needs than what is required, particularly due to companies wanting their product to be safe and the best in th...

Design controls play an important role in ensuring that the product is high quality and fully functional. Having detailed inputs that take into account all aspects of the device and its function will ...

As mentioned in the lecture and by others on this post, when determining inputs for a device the marketing team is included in the discussions. The customer needs research done by the marketing team w...

I recall for my senior capstone project we had to do verification and validation testing on our device and I had difficulty understanding what differentiated the two types of testing. Essentially, ver...