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Forum Replies Created

RE: how far is "As Far As Possible"

Reducing risks “as far as possible” is definitely a huge challenge for manufactures. I believe that the statement implies that not all of the risks can be reduced 100%, but it should be reduced as muc...

In forum Risk Analysis for Medical Devices

9 years ago
RE: Risk Management Mistakes

Wow, reading this was extremely interesting and a definite eye-opener. It is an interesting discussion. Companies should perform risk assessments throughout the entire lifecycle of the product—even wh...

In forum Risk Analysis for Medical Devices

9 years ago
RE: Expense of Regulations

I agree with other students in regards to offering the company a subscription where they can access a database that supplies access to all of the necessary documents. Employees will continually have a...

In forum Risk Analysis for Medical Devices

9 years ago
RE: Important Part of DDP

In my opinion, it is very difficult to claim one portion of the DDP as the “most important.” However, if I had to choose a certain aspect that is important in the plan, the scope management plan stand...

In forum Introduction to Design Controls

9 years ago
RE: Minutes for meetings

The last thing a manager or an employee wants to do at a meeting is to take the minutes. However, it is an extremely important and necessary task for multiple reasons. A person’s memory is unreliable ...

In forum Introduction to Design Controls

9 years ago
RE: Design Transfer and Challenges

Out of all of the stages that a company’s product goes through, design transfer is the most important. In this stage, the design of the product is introduced to production and requires a full evaluati...

In forum Introduction to Design Controls

9 years ago
RE: What are Design Controls?

Safety is a key factor when designing and developing a medical device. Regulatory bodies, such as the FDA, wants assurance that the medical device is safe before bringing the product to the market. Th...

In forum Introduction to Design Controls

9 years ago
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