To further add to the discussion, in cases where a medical device incorporates technology developed externally, technology transfer agreements can transfer the risks associated with the technology's p...

Hello everyone, My name Mariya, and I am a Master's student in BME department at NJIT. Here is my LinkedIn page: I look forward to connecting with you!

Exploring the PMI triangle discussed in PMBOK Chapter 3, it raises the question of the significance of strategic and business management skills, coupled with leadership qualities, for a Project Manage...

I second to the fact that avoidance is easily incorporated in the product design phase due to multiple reasons, such as 1. During product design phase there are many changes to be made according to th...

I side with @afshinsadri, that the effectiveness of a leadership style depends on the nature of the project, team dynamics, and organizational culture, and project managers may need to adapt their lea...

The medical device industry, like any other, faces specific challenges during the project initiation phase. Some of the challenges and probable ways to address them that come to my mind are: - 1. Chan...

This week was focused on Project, Products and Organizations. Towards the end that is after Input, Verification, Validation and Transfer comes the Design Review Meetings. My questions is, as a projec...

This an interesting and a wide topic of discussion. In my opinion as an Engineer, in the medical device industry, a project manager with an academic background, including basic science or advanced deg...

Within a Design and Development Plan (DDP), sub-planning planning involves breaking down the overall design and development process into discrete elements, each of which needs a customized strategy. ...

Misclassification of a medical device can harm the manufacturer’s reputation. Stakeholders, including healthcare providers and end users, rely on accurate information about device classification to ma...

Additionally, the way that medications and medical equipment are administered differs significantly from one another. Usually, drugs are given by ingestion, injection, or inhalation, allowing them to ...

The FDA plays a pivotal role in ensuring the safety and efficacy of medical devices. Understanding and adhering to FDA regulations is not only a legal requirement but also a fundamental aspect of deli...

In the PDCA process within the field of Biomedical Engineering, employees with different specialties are often involved in all stages of the cycle. The multidisciplinary nature of Biomedical Engineeri...

As highlighted by @Zeinab Amoabediny development of medical devices is a complex process and also involves interdisciplinary collaborations such as engineering, design, regulatory affairs, and clinica...

According to W. Edwards Deming, the father of modern quality theory and the science of process management, higher quality outcomes eliminate waste/Healthcare waste (i.e., any consumption of resources ...