In order to create a robust final product, it is important to understand the worst-case scenario outcomes. If a product undergoes rigorous testing of ...

I completely agree with your perspective that the Design History File (DHF) should be treated as an active part of the product development process rat...

The verification failure shows the importance of integrating a strong risk management framework and focusing on continuous improvement in medical devi...

Balancing structure and flexibility in medical device development requires developing an approach that fits organizational structure with project need...

Filing for FDA approval of a misclassified device can cause major hinderances to the entire process, whether the company filed a class II device as cl...

Organizations can find a balance between regulatory compliance and innovation without compromising agility by practicing open communication, involving...

When considering using new technology in a project, the PM must take into consideration the impact to the overall cost and timeline of the project. If...

A strong regulatory strategy is essential for effective project management in the medical device industry, as it reduces risks such as costly delays, ...

The biggest regulatory challenge in developing emerging medical technologies involving AI or machine learning is finding a balance between adhering to...

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...