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mme54
@mme54
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Joined: Sep 10, 2023
Last seen: Nov 28, 2023
Topics: 1 / Replies: 47
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RE: When is giving gifts like the "old days" too much?

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,...

12 months ago
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RE: Confidential Agreement Secrecy

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...

12 months ago
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RE: Contract Law components examples

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...

12 months ago
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RE: Discussion Topic: Your organizational type

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...

12 months ago
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RE: Organization Type vs. Effectiveness

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...

12 months ago
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RE: Organization Types: Which one benefits you?

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...

12 months ago
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RE: Benefits of post-market surveillance

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

12 months ago
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RE: What is Risk-benefit analysis ?

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...

12 months ago
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RE: Discussion Topic: Risk Management, Risk Analysis

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...

12 months ago
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RE: Design Output

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 ...

1 year ago
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RE: Corporate Responsibility?

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...

1 year ago
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RE: Design Review Meetings: Attendance & Causes for Scheduling

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...

1 year ago
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RE: Initializing Design Controls

To effectively reassess and potentially enhance the design controls for a medical device, it is crucial to commence by comprehending the underlying re...

1 year ago
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RE: Steps of Process Validation

I've come to understand that medical device process validation plays a crucial role in ensuring the consistent production of high-quality medical devi...

1 year ago
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RE: Discussion Topic: Supplemental on DHF and DMR

As a student, I recognize that when developing a medical device in the European Union (EU), the regulatory framework differs from that in the United S...

1 year ago
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