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 undergoing routine maintenance…   Read more»

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 documentations. My professor would use the term “idiot-proof”…   Read more»

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 Design History File is created during the product…   Read more»

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, including but not limited to SOPs,…   Read more»

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. Verification is showing that what the project defined as their requirements of the design…   Read more»

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 itself is…   Read more»

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 these designs so…   Read more»

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 Notified Bodies, which have more central…   Read more»

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 consideration devices being safe…   Read more»

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 applying and working…   Read more»

From my understanding, you would need to first have a patent to protect your ideas. An NDA protects you from other people that get involved in the project. You may need to have both to fully protect your ideas, especially…   Read more»

The restriction of physician’s gifts is a guideline for companies to follow to avoid being accused of bribery or influencing their decision to be involved with a project. While it is a bit strict and some may find it unnecessary,…   Read more»

I believe from the point of view of a project manager, it can be the most challenging to work in a matrix organization. This comes from the conflict of everyone having at least two distinctly separate bosses. The project manager…   Read more»

I currently work in a functional organization, which to my understanding is the most traditional form of business organization. There are functional managers of each department, such as Manufacturing, Quality, Purchasing, and R&D. Within these, there are individual staff members…   Read more»

When forming a project team, it is important to consider someone’s skill as well as their personable skills. It is important to get along well with everyone on the team. It is not always ideal to choose close friends as…   Read more»

I think in the context of any other field, As Far As Possible is daunting and almost unattainable. However, in medical devices and anything else regulated by the FDA, it is necessary. The goal of the FDA is to have…   Read more»

It seems like a fair trade-off, especially for more established companies that know what their goals and needs are. However, for new companies like start ups, it would make sense to have some way to rent the material before purchasing…   Read more»

Our company uses FMEA, which only differs from the acronym for FMECA by the one word “criticality”. In an FMEA, the Failure Mode Effects Analysis addresses potential risks of the product, whether in production or distribution. There is an extensive…   Read more»

The ultimate goal of the FDA is to ensure that products are safe and effective. These are the two most crucial factors of a medical device. For design control systems, the FDA is making sure that every phase in the…   Read more»

I am currently in Capstone I, and we have completed the phase of customer needs and business requirements. This phase is very similar to the process in industry, as we are learning in the course. Through gathering customer needs, we…   Read more»