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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

10 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

10 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

10 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

10 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

10 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

10 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

10 years ago
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