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kdg4 replied to the topic "Written Agreement v/s Verbal Agreement" – 4 years, 10 months ago
Both written and verbal can be very useful, but I would think that a verbal agreement should be followed up with a written agreement. A verbal can be good to work out the terms, but once on paper those terms… Read more»
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kdg4 replied to the topic "Recent Examples of Kickback Allegations" – 4 years, 10 months ago
In terms of kickbacks, maybe a lot of these happen because some people may not think it is a big deal to accept to those things. Maybe it is just thought of as the cost of doing business in the… Read more»
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kdg4 replied to the topic "Discussion Topic: Course conclusion and impressions" – 4 years, 10 months ago
This course has been very useful to show people what could really be expected of them when they get into the real world. It was good to see the different stages of developing a medical device, and what is expected… Read more»
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kdg4 replied to the topic "Organization types of medical devices?" – 4 years, 10 months ago
The idea of the matrix organization seems to be a great idea for forming a project team. It will give the project manager an opportunity to really pick those people who may be best for that particular project. Sometimes people… Read more»
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kdg4 replied to the topic "Forming a Project Team" – 4 years, 10 months ago
When working with people you may not know, that could be a good thing to allow for different ideas to come about. If you are not used to working with a certain person it may take some time to develop… Read more»
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kdg4 replied to the topic "Project Management Preferences" – 4 years, 10 months ago
The hardest part of a matrix based organization would seem to be getting people to be on their project team. If a person if involved in other projects it may be hard to coordinate with that person to get them… Read more»
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kdg4 replied to the topic "Expense of Regulations" – 4 years, 10 months ago
I understand that having to pay may just be the cost of doing business, but I do agree having a database would be helpful to those smaller companies. Some smaller companies may have such innovative ideas and be able to… Read more»
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kdg4 replied to the topic "Risk management methods" – 4 years, 10 months ago
FMEA does sound interesting Roberto. By being able to make sure you device fails and then fixing those failures could be a way to have a stronger more reliable product. On the flip side, if you are unable to fix… Read more»
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kdg4 replied to the topic "Risk analysis in real company" – 4 years, 10 months ago
A meeting to determine if a project is a go or no go seems to rely heavily on the risk management. It seems like a good idea to have multiple departments involved in this process to fully identify the risks… Read more»
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kdg4 replied to the topic "Design Transfer" – 4 years, 10 months ago
When it comes to outsourcing, it seems that it can be a very hard process. The company wants to make sure their vendor is doing everything properly when they transfer it over. This would mean their is nothing left to… Read more»
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kdg4 replied to the topic "Design Review Meetings" – 4 years, 10 months ago
I unfortunately do not have industry experience in a design review, but I can imagine how these meetings impact the development of the project. During these meetings it must also be important to stay on top of the changes that… Read more»
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kdg4 replied to the topic "Minutes for meetings" – 4 years, 10 months ago
Meeting minutes are important to recap what was said or done in a meeting. I have been tasked with taking minutes, but I know that no one really read them. It would be just sent to the manager and uploaded… Read more»
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kdg4 replied to the topic "What are Design Controls?" – 4 years, 10 months ago
It seems that design controls can be ever changing with how the device is developed over time. Reading over the previous replies, it is true that companies can not change the design controls forever. If that were the case then… Read more»
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kdg4 replied to the topic "Important Part of DDP" – 4 years, 10 months ago
A very important part of the DDP is the scope management plan. If the scope of the project is not clearly defined and kept in focus nothing will get done to move the project forward. Once people working on the… Read more»
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kdg4 replied to the topic "Consequences Of Insufficient Design Controls" – 4 years, 10 months ago
When the process is not used properly, it results in a failed medical device as stated by those examples above. In the case of those recalled medical devices, it would be interesting to know what their design controls were and… Read more»
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kdg4 replied to the topic "Discussion Topic: Is the DHF a living document?" – 4 years, 10 months ago
In my opinion it seems that the DHF could be a combination of the two. There could be some things that do not change throughout the design process, and then there could be things that are updated. Considering how much… Read more»
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kdg4 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 7 years, 3 months ago
Both written and verbal can be very useful, but I would think that a verbal agreement should be followed up with a written agreement. A verbal can be good to work out the terms, but once on paper those terms are clear to both parties and it will be signed to show both agree. In the written you can capture everything that is needed, which may be…[Read more]
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kdg4 replied to the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics 7 years, 3 months ago
In terms of kickbacks, maybe a lot of these happen because some people may not think it is a big deal to accept to those things. Maybe it is just thought of as the cost of doing business in the field, and that has almost become a norm. Since it has been happening for a long time, those people in the industry have just become desensitized and…[Read more]
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kdg4 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics 7 years, 4 months ago
This course has been very useful to show people what could really be expected of them when they get into the real world. It was good to see the different stages of developing a medical device, and what is expected in every step. Project management as a whole is something that can be useful to everyone even if they are specifically a project…[Read more]
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kdg4 replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies 7 years, 4 months ago
The idea of the matrix organization seems to be a great idea for forming a project team. It will give the project manager an opportunity to really pick those people who may be best for that particular project. Sometimes people may have a certain niche that will really benefit a project and if the project manager is able to capitalize on that, it…[Read more]
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