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Naglaa Hemida
@naglaa-hemida
Trusted Member
Joined: Jan 24, 2021
Last seen: Nov 28, 2021
Topics: 13 / Replies: 65
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RE: Discussion Topic: Course conclusion and impressions

This training has been quite beneficial in showing folks what might be expected of them in the real world. It was interesting to observe the many stag...

2 years ago
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RE: Written Agreement v/s Verbal Agreement

It seems logical to me that these rules are in place. You could think it's a little too limiting, but they need to be there. My father was a doctor in...

2 years ago
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RE: Restrictions for physician's gifts

It seems logical to me that these rules are in place. You could think it's a little too limiting, but they need to be there. My father was a doctor in...

2 years ago
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RE: Organization Type vs. Effectiveness

When deciding which organizational structure is ideal for a company, the size of the company must be taken into account. The organizational structure ...

2 years ago
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RE: Organization types of medical devices?

I would suggest establishing the startup company as a functional organization from the outset. As stated in the lecture, this type of structure is app...

2 years ago
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RE: Forming a Project Team

It's critical to hire the proper personnel for a successful project team. Professional performance, as well as personal traits, must be evaluated. We ...

2 years ago
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RE: Risk Management Mistakes

The prototype system is being exploited in product development since it does not consider important risk factors. I learned about this risk management...

2 years ago
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RE: Factors Contributing to Risk Values

Additional criteria should be considered when calculating the risk value. In most cases, EDP audit teams search for both threats and vulnerabilities i...

2 years ago
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RE: Risk management and Labels

In my perspective, risk management starts with end-user training and education. It is incumbent to a corporation to educate the end-user population to...

2 years ago
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RE: When is validation is not required?

Validation is necessary to verify whether the gadget satisfies the user's demands and is fit for its intended purpose; it also aids the corporation in...

2 years ago
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RE: Customer Needs and Design Input

One of the benefits of the DID document is that it gives you a broad idea of how the finished product will look. This is essentially a mental image of...

2 years ago
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RE: Design Controls in the other countries

The Turkish Medicines and Medical Devices Agency is in charge of design control in Turkey. It adheres to ISO 13485 and ISO 9001 standards. Medical dev...

2 years ago
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RE: Factors to Consider While making Gantt Chart

One thing I've learned is that no matter how much planning you do, some situations are beyond your control. In my field, for example, we must do multi...

2 years ago
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RE: What are Design Controls?

The FDA mandates design controls, which are used to assure traceability of issued products. The notion is that if a released product has a flaw that i...

2 years ago
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RE: Minutes for meetings

Meeting minutes are indeed a significant element of the device's design change and development process. The value of meeting minutes varies depending ...

2 years ago
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