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 instance, the two series of medical device developme...

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 long process to find the issue, there are...

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 experience, I have been in companies that make sure to ...

I agree with the posts above. The ISO standard provides the flexibility needed to accommodate the needs of the companies but still providing the necessary regulation to process output. But from the FD...

When encountering the movement of equipment in production, I believe that a re-validation is a necessary step. However, as some have mentioned above, it must be identified if a full Validation process...

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 that show how it can expedite the process a produc...

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 the activities during the design and development pro...

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 type of detail that goes into the SOP is crucial to ...

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 get the base standards in place. The tough part is ...

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, it may create more modifications within the regulat...

During this week’s lecture, Dr. Simon discussed about SOP's and how they are part of the integrated quality system. He also described how they are important/required to be part of any GMP process. Do ...

I agree with the comments provided so far. The importance of post-market surveillance is to provide the necessary information on the product being used by patients and confirming that is maintaining t...

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 change in a minor detail of the aesthetics of the dev...

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 instance, if the device is design to be coated black and...

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. However, after the design transfer process is compl...