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 |