Balancing stakeholder and customer values is indeed a multifaceted challenge for project managers, requiring a clear understanding of each group's priorities and the project's overarching goals. A cas...

I completely agree that project management is the backbone of successful medical device development, and both the regulatory and cross-functional collaboration challenges mentioned are spot on. One of...

Risk management is indeed a critical part of medical device project management, and the points raised about regulatory risks are spot on. In my experience, the biggest risks often come from the interp...

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, if a group has succeded in doing a project, the c...

From Simon's lecture, one could point out that essential factors of the confidentiality agreement would be the same as the contractor law regarding the offer and acceptance, Consideration, Intention t...

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 acceptance. An offer, which is a clear and specific p...

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 specific fundamental skills: Sealing, welding, and Sepax ...

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 goals, and the industry it operates in. Each struct...

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 organization. Unlike function-based structures, project-base...

In addition to the swift identification of necessary improvements, post-market surveillance (PMS) offers multifaceted benefits crucial for maintaining the safety and effectiveness of medical devices i...

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 never 100% certainty when determining the safety ...

ISO 14971 is well-recognized by FDA around the world for risk Management. This standard sets forth vital requirements for establishing a robust risk management process throughout the entirety of the 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 the safety and effectiveness of these devices. Des...

In my perspective, there can be numerous compelling reasons for an interim design review meeting. A significant rationale for such a meeting may be the discovery of a design flaw, necessitating a rede...

In my perspective, there can be numerous compelling reasons for an interim design review meeting. A significant rationale for such a meeting may be the discovery of a design flaw, necessitating a rede...