For my experience, this is the fourth class I have taken with Dr. Simon and the content itself has been very helpful to relate to the industry. For in...
I agree with the posts above. The investigation is definitely a key parts that should occur first to be able to find the answer. Even though sometimes...
It is a good point brought up that the setbacks are definitely crucial to be taken into account during any product planning process. And with my exper...
I agree with the posts above. The ISO standard provides the flexibility needed to accommodate the needs of the companies but still providing the neces...
When encountering the movement of equipment in production, I believe that a re-validation is a necessary step. However, as some have mentioned above, ...
Chris, This is a type of qualification that I have not encountered within my daily work but it is interesting to read about it. I found a few details...
This link definitely provides a great representation of the difference between the two. Some key aspects of the DHF that are mentioned are that all th...
I agree with the comments above that an SOP is a step by step process that provides guidance to the person reading the procedures. In addition, the ty...
I definitely agree with the QMS system in a small company can start off with various obstacles. But in a sense, it is a necessary rite of passage to g...
As mentioned above and within Dr. Simon’s video, the ECO is required when the design controls are finished and the device needs a change. With this, i...
I agree with the comments provided so far. The importance of post-market surveillance is to provide the necessary information on the product being use...
This is an interesting question. In my opinion, it may depend on the type of changed specifications and how that may affect the device. If it is a cha...
The verification is when the tests are created for each specification in the DSD to confirm that the design input equals the design output. For instan...
I would agree that the DHF is considered a living document due to its importance in holding all the required information during the design controls. H...