Last seen: Feb 9, 2025
The FMEA is most valuable when determining the risks on a device. It can detect additional failure modes that add to the list of possible risks. It de...
I agree that risk avoidance is the best way to deal with any level of risk, especially in manufacturing. However, mitigation tools and acceptance crit...
To determine the acceptable level of risk, it's important to follow the Risk Management Process. First, do a Risk Analysis and Estimation to list the ...
Hi elm33, After this week's lecture, I feel a lot safer knowing about Verification/Validation. These steps are there to catch flaws early on, and if...
Verification tests whether design outputs match design inputs. Validation tests whether design outputs satisfies user needs. In my previous job as a Q...
One way to improve design transfer is to implement the use of CAD drawings so manufacturing can better understand how to make the product. This can in...
Companies will have Design Input and Design Specification documents in their DHF. They might not have a Design output because the Design specification...
Software Validation has many advantages. Software validation ensures that the device meets regulatory standards. This makes for quicker regulatory app...
Validation is very important to ensure that the costumer needs are met. This may involve using Human Clinical Trials. This is a step further that Desi...
Placebo affects do not negatively impact a clinical trial. The Placebo group if compared with itself before comparing with the treatment group. Over m...
I believe that in some cases it's ok, where in other cases it's not. In the case of a drug that required an IDE, it might be a good incentive just in ...
In a double-blind study, both the Investigator and Patient don't know whether they're being given the placebo or actual results. In a single-blind stu...
I agree that providing clear evidence based data on safety and effectiveness is important for doctor's and patients. I think that patients want to fee...
Product development is mainly responsible for research and development of devices. They are preoccupied with testing prototypes and designs for either...
I agree that Sales and Marketing are important for Medical Device companies to meet the needs of costumers and deliver their final product to them. Ma...