Last seen: May 9, 2025
Balancing stakeholder and customer values is indeed a multifaceted challenge for project managers, requiring a clear understanding of each group's pri...
I completely agree that project management is the backbone of successful medical device development, and both the regulatory and cross-functional coll...
Risk management is indeed a critical part of medical device project management, and the points raised about regulatory risks are spot on. In my experi...
I didn't experience gift-giving in the corporate world but I think gift-giving is legal but could be used as bribery based on intentions. for example,...
From Simon's lecture, one could point out that essential factors of the confidentiality agreement would be the same as the contractor law regarding th...
In contract law, several key components are crucial for the formation and validity of a contract. First and foremost are the elements of offer and acc...
I think I work in a Functional organization as every employee is doing specific roles like me as a Manufacturing operator in the company using specifi...
In my opinion, there isn't a one-size-fits-all answer to the best organizational structure, as it largely depends on the nature of the business, its g...
In reflection on the types of organizations discussed in this week's lecture, I find that I would be comfortable working in a project-based organizati...
In addition to the swift identification of necessary improvements, post-market surveillance (PMS) offers multifaceted benefits crucial for maintaining...
one factor that the FDA considers when evaluating the benefit-risk profile of a medical device is the uncertainty associated with the device. There is...
ISO 14971 is well-recognized by FDA around the world for risk Management. This standard sets forth vital requirements for establishing a robust risk m...
As a student delving into the realm of medical device development, I've come to appreciate the pivotal role played by Design Controls in guaranteeing ...
In my perspective, there can be numerous compelling reasons for an interim design review meeting. A significant rationale for such a meeting may be th...
In my perspective, there can be numerous compelling reasons for an interim design review meeting. A significant rationale for such a meeting may be th...