At times it is very unlikely to be able to eliminate all risk in a medical device. The article posted above does a great job explaining what “as far as possible” implies in the IPO. This just ensures that the cost to reduce the risk has absolutely no influence whether the risk is considered acceptable or not. Without this companies would try and…[Read more]

For low severity risks you are either going use acceptance or mitigation. You are going to have to determine if the benefit is worth the risk. If the benefit is worth the severity of risk you are taking on you can accept the risk and go on with our product. If the benefit is not significant enough for the risk you are going to have to mitigate…[Read more]

There has been very good points made as to the benefits of large and small companies outsourcing for their design transfer into manufacturing process. I agree that small companies will often benefit from outsourcing the manufacturing process because often times they will not have the sufficient equipment available to manufacture their product…[Read more]

There has been very good points made as to the benefits of large and small companies outsourcing for their design transfer into manufacturing process. I agree that small companies will often benefit from outsourcing the manufacturing process because often times they will not have the sufficient equipment available to manufacture their product…[Read more]

The verification and validation reports provide evidence for a company that their product inputs will directly lead to the product output. In order to confirm this is true you must design a test to validate the claims. These tests that Dr. Simon mentioned are going to differ according to different projects. As our classmates have discovered…[Read more]

Although I have not yet been involved in a company meeting where meeting minutes were documented I can see why Dr. Simon has stressed the importance of the minutes in his lectures. These meeting minutes help document all vital information obtained from the meeting and can act as evidence for your role in the project if there is any issues with…[Read more]

As our classmates have previously mentioned lapses in the design control benefit no one and are just dangerous for the consumers. As a company manufacturing and distributing novice medical devices coming in contact with human subjects must guarantee safety. If companies start taking lapses in their design controls it is going to decrease the…[Read more]