Last seen: Mar 1, 2025
A project manager can keep project goals dynamic while avoiding scope creep and ensuring successful delivery by establishing a strong framework for co...
When it comes to working within a team virtually, I find that the best way to effectively communicate is finding the right platform and giving everyon...
In my opinion, a balanced combination of in-person and virtual communication can be used in successful project management. I do not think it necessary...
Verbal contracts are much less common than written contracts in the medical device industry, but they can be important in situations where an immediat...
To keep up with the shift toward value-based healthcare, medical device companies should prioritize patient outcomes, operational efficiency, and work...
Risk management is extremely important to the medical device sector. Here are a few examples of each of the 4 strategies discussed in the lecture rela...
There are ISO and FDA standards that frame how risk management should be handled when it comes to medical devices. According to ISO 14971, risk analys...
When companies interpret standards like ISO 13485 and 21 CFR 820.30, several factors influence their approach. These interpretations show the balance ...
Verification and validation each have their own distinct purposes. Verification ensures that a design meets specific technical requirements and valida...
Customer feedback is very important to the design input process because it drives user needs. In some cases, feedback can be ambiguous and cause chall...
It is possible that teams log additional design inputs beyond the requirements for different reasons, including predictive measures, future risk preve...
A DHF can become overwhelming if not managed correctly. Some ways to mitigate this are to organize the DHF by development phase to make it easy for an...
Validation processes such as testing and verification are if utmost importance to product development across all industries. In my experience, these p...
In clinical trials, effective communication among sponsors, investigators, CROs, and IRBs is crucial when handling unexpected adverse events. I believ...
I think in most cases it is appropriate to offer patients in a clinical trial payment for their participation. Being involved in a clinical trial ofte...