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Forum Replies Created

RE: Discussion Topic: Course conclusion and impressions

I am very glad I took this course. It gave me the overview I needed to understand more of how things work in the industry. I know certain topics are more complex than others and they could even take a...

In forum Consultants and Legal Basics

6 years ago
RE: Restrictions for physician's gifts

I think the restrictions are not out of place. You are attending a business discussion and family members should not be involved. It should be understood in the doctor's side that only his meal will b...

In forum Consultants and Legal Basics

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

An oral agreement can include forms of oral agreement and a written contract. A verbal agreement is made without a formal written documentation. While the agreement is there and understood in spoken w...

In forum Consultants and Legal Basics

6 years ago
RE: Upper vs Middle Management.

Personally, I think I would be suited for either one. Middle management is essential to understand the vision and I think this is where experience is very important. To begin my career I need to start...

In forum Organizational Development in Device Companies

6 years ago
RE: Forming a Project Team

As it's mentioned quite a few times in the previous posts, in a real-life scenario you most likely won't have the opportunity to finger pick the persons you want to work with. I think, if you are give...

In forum Organizational Development in Device Companies

6 years ago
RE: Discussion Topic: Your organizational type

Previously I worked in a project-based organization. Although I was just an intern, I got to experience how the projects were worked out within the department. The projects I was involved in required ...

In forum Organizational Development in Device Companies

6 years ago
RE: Risk management and Labels

Once the product is out in the market, and the company has done everything possible it is up to the user to use the product as indicated. The company should have written clear labels and directions as...

In forum Risk Analysis for Medical Devices

6 years ago
RE: How to run a risk management meeting ?

Risk meetings should have an agenda that everyone is already aware of. This way all attendees know what the meeting will be about. I think breaking down the risks in categories is a good idea because ...

In forum Risk Analysis for Medical Devices

6 years ago
RE: What is Risk-benefit analysis ?

One of the factors is Assessment of the Benefits of Devices. In this assessment, the FDA takes into account the types of benefits that the device has on patient health as well as their satisfaction. T...

In forum Risk Analysis for Medical Devices

6 years ago
RE: What are Design Controls?

Design controls have a specific objective and its to assure that the device meets the user needs, intended uses and specified requirements. Design controls also serve as a way to continue improving th...

In forum Introduction to Design Controls

6 years ago
RE: Design input sources

Design input sources can vary depending on what could be the most efficient way to obtain them. Many times, market analysis can offer significant information about a product. Technical research is als...

In forum Introduction to Design Controls

6 years ago
RE: Why VERIFICATION is important? and Your ideas to improve Verification process ?

I agree with the verification points mentioned above as well. Verification process makes an emphasis on attention to detail, to avoid major mistakes. Early verification can be helpful to study the pro...

In forum Introduction to Design Controls

6 years ago
RE: Design Documents in Academia

In research, documentation is also very important. Besides protocols, laboratory notebooks are highly useful because here it's where you can find specifications of a procedure or a concept that can he...

In forum Introduction to Design Controls

6 years ago
RE: Customer Needs and Design Input

Advantages of DID is that serves as an overall/general description of the product it also states the design input as clear and objective without numerical specifications. The major disadvantage with D...

In forum Introduction to Design Controls

6 years ago
RE: Minutes for meetings

I agree that meeting minutes are highly useful. During my internship, I took minutes during meetings without being asked to. I found that directors liked that and complimented me to taking part in tha...

In forum Introduction to Design Controls

6 years ago
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