Last seen: Mar 1, 2025
In my experience, the most present risk in nearly every project is usually schedule risk. Deadlines are often affected by unexpected delays, resource ...
Cost estimation is a major challenge, especially in highly regulated industries like medical devices where unexpected compliance hurdles or clinical t...
I would agree that many teams struggle with identifying which tasks are truly critical versus those with flexibility, leading to wasted resources and ...
Balancing design controls with flexibility needed for innovation is essential in regulated industries like medical devices. To achieve this, companies...
Hi everyone, my name is Megan and I am currently pursuing my MS in BME at NJIT. Connect with me below: linkedin.com/in/megan-crawford-180324294
A work breakdown structure (WBS) facilitates better project planning by providing a clear definition of the project’s scope and breaking it down into ...
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...