A project manager can keep project goals dynamic while avoiding scope creep and ensuring successful delivery by establishing a strong framework for continuously updating goals as they change and commu...

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 everyone enough time to engage. The first aspect of team ...

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 to go all in on either method of communication, b...

Verbal contracts are much less common than written contracts in the medical device industry, but they can be important in situations where an immediate agreement or quick decision is required. Compani...

To keep up with the shift toward value-based healthcare, medical device companies should prioritize patient outcomes, operational efficiency, and working closely with healthcare stakeholders. One appr...

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 related to a hypothetical heart implant company: Risk ...

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 analysis should include identifying potential hazards an...

When companies interpret standards like ISO 13485 and 21 CFR 820.30, several factors influence their approach. These interpretations show the balance between strict regulatory compliance and the compa...

Verification and validation each have their own distinct purposes. Verification ensures that a design meets specific technical requirements and validation ensures that the design meets the user needs....

Customer feedback is very important to the design input process because it drives user needs. In some cases, feedback can be ambiguous and cause challenges in translating the designs into reality. Som...

It is possible that teams log additional design inputs beyond the requirements for different reasons, including predictive measures, future risk prevention, or preparing for later iterations of the pr...

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 any reader to follow the development process, group ...

Validation processes such as testing and verification are if utmost importance to product development across all industries. In my experience, these processes play a crucial role in identifying defect...

In clinical trials, effective communication among sponsors, investigators, CROs, and IRBs is crucial when handling unexpected adverse events. I believe that it would be beneficial to have a standardiz...

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 often involves time and travel of being treated and co...