There is always a push and pull between keeping companies as is, and moving forward towards innovation. In my experience, there has always been individuals that have been in place for so long that the...

I have had experience with obsoleting product in my company that had been cumbersome to carry as a product. These were product that had not been making the amount of money that was worth the cost of p...

It would vary with each company, but even if the equipment does not go through the entire validation process again, it does have to keep up with calibration expiration as well as preventive maintenanc...

It is important to have preventative action in medical devices because once a negative effect happens, it has already been out on the market if it was not prevented and this could cost lives. Reactive...

I have come across this issue with a certain gauge that was applicable to several parts of the production process. The manufacturing department argued that it can just be specified that this gauge has...

I agree with the posts above, depending on the degree of failure and the complexity of the machine, it may need to undergo IQ OQ PQ again to ensure safety and efficacy. However, if it is just undergoi...

In my undergraduate experience, I took Capstone which was a two-semester long simulation of what industry is like. This class exposed me to technical writing in order to make clear and concise documen...

There is a vast difference between the Design History File (DHF) and the Device History Record (DHR). Once the timeline during which these are created is understood, the difference is apparent. The De...

Our company uses ECOs and refers to them as Change Notices, as these can be originated by non-engineering as well. These CNs serve to make revisions to any document in the Quality Management System, i...

Regarding verification and validation themselves, the difference lies in what is being confirmed. Verification is the confirmation that the design output meets the design input requirements. Verificat...

I agree with the above points that this debate would have to be on a case by case basis. If there is a failure in V&V testing, it is primarily important to make sure that your testing method itsel...

It is most sensible for the DHF to be a living document, as updates are made and the design revised, it must be permanently logged. Even post design transfer, it is important to update the origin of t...

I would consider the NB-MED guidance document to be the most useful and most powerful. This is based on the governing power that writes said document. The NB-MED guidance documents are written by the ...

It is apparent that it is easier to have a medical device approved in the EU versus in the US, possibly due to the simplified yet still effective method of approval. Where the FDA takes into considera...

I have not personally had this experience as it is early on in my career. However, I do have a colleague who interned at Zimmer Biomet, and as a result, the non-compete agreement had barred him from a...