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Dhairya Parekh replied to the topic "Written Agreement v/s Verbal Agreement" – 5 years, 10 months ago
Advantages of written agreement: The main advantage to the drawing up of contracts to minimize liabilities is that it reduces the risk that the company issuing the contracts will be sued. By making sure that all parties agree on the… Read more»
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Dhairya Parekh replied to the topic "Written Agreement v/s Verbal Agreement" – 5 years, 10 months ago
There are several disadvantages of verbal contract. The most common argument against a verbal contract is the lack of solid evidence. Since we are dealing with medical device, we have to keep in mind that most likely medical devices will… Read more»
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Dhairya Parekh replied to the topic "Discussion Topic: Course conclusion and impressions" – 5 years, 10 months ago
Dr. Simon, There are two things that I really liked about this course. One is that it gives a good understanding of each department in medical device industries. So, this way student taking this course can decide which department is… Read more»
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Dhairya Parekh replied to the topic "Project Management Preferences" – 5 years, 10 months ago
It will be very difficult for project manager to work in matrix organization. There are several problems that can arise. There is three main difficulties that project managers might face: secrecy and deception, time constraints, and contradictions. When people report… Read more»
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Dhairya Parekh replied to the topic "Forming a Project Team" – 5 years, 10 months ago
Picking a project team is very crucial for a successful project execution and completion. You have to pick the right people for the job. It doesn’t always mean you have to get the most experienced people. Don’t confuse experience with… Read more»
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Dhairya Parekh replied to the topic "Discussion Topic: Your organizational type" – 5 years, 10 months ago
I would like to work in matrix organizational structure because it brings together employees and managers from different departments to work toward accomplishing a goal. There are advantages of implementing the matrix organizational structure in a business. It can lead… Read more»
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Dhairya Parekh replied to the topic "Manage Risk" – 5 years, 10 months ago
I certainly agree with everyone that acceptance would not reduce any risk out of these four. Accepting the risk means that once you have identified it, you take no action. You simply accept that it might happen and decide to… Read more»
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Dhairya Parekh replied to the topic "Risk Identification" – 5 years, 10 months ago
I have had the opportunity to work on risk analysis at the company that I worked for in past. The risks were given numerical values based on three categories and the total risk was the product of these categories. It… Read more»
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Dhairya Parekh replied to the topic "Design input sources" – 5 years, 10 months ago
Source of design input is the market research of the product. What it is that is needed. From this you can figure the customer needs. Once the customer needs are set, it is easier to plan design inputs. For an… Read more»
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Dhairya Parekh replied to the topic "Design Verification & Validation" – 5 years, 10 months ago
It is very important to know the difference between verification and validation plan while working in medical device company. It was also not clear to me in the beginning but once after working on a project during capstone, it became… Read more»
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Dhairya Parekh posted a new topic "Manage Risk" – 5 years, 10 months ago
Creating a list of risk is a good starting point, however, it is not enough on itself. You also need an action plan for each risk in order to be able to manage them effectively. We learned about the standard… Read more»
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Dhairya Parekh replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 8 years, 4 months ago
Advantages of written agreement:
The main advantage to the drawing up of contracts to minimize liabilities is that it reduces the risk that the company issuing the contracts will be sued. By making sure that all parties agree on the terms of a particular agreement and making everyone sign a contract attesting to this, this strategy reduces the…[Read more] -
Dhairya Parekh replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 8 years, 4 months ago
There are several disadvantages of verbal contract. The most common argument against a verbal contract is the lack of solid evidence. Since we are dealing with medical device, we have to keep in mind that most likely medical devices will deal with multiple lawsuits. If we rely on verbal agreement, medical device company will most likely loose.…[Read more]
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Dhairya Parekh replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics 8 years, 4 months ago
Dr. Simon,
There are two things that I really liked about this course. One is that it gives a good understanding of each department in medical device industries. So, this way student taking this course can decide which department is more suitable for them. I personally would not enjoy working as QA or clinical. Secondly, I like the idea of how…[Read more] -
Dhairya Parekh replied to the topic Project Management Preferences in the forum Organizational Development in Device Companies 8 years, 4 months ago
It will be very difficult for project manager to work in matrix organization. There are several problems that can arise. There is three main difficulties that project managers might face: secrecy and deception, time constraints, and contradictions. When people report to multiple bosses, problems may occur. Interpersonal conflicts inevitably…[Read more]
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Dhairya Parekh replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies 8 years, 4 months ago
Picking a project team is very crucial for a successful project execution and completion. You have to pick the right people for the job. It doesn’t always mean you have to get the most experienced people. Don’t confuse experience with output. When I look to build my team, what I look for is getting people with minimum skill requirements so the…[Read more]
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Dhairya Parekh replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies 8 years, 4 months ago
I would like to work in matrix organizational structure because it brings together employees and managers from different departments to work toward accomplishing a goal. There are advantages of implementing the matrix organizational structure in a business. It can lead to an efficient exchange of information and departments can work closely…[Read more]
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Dhairya Parekh replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
I certainly agree with everyone that acceptance would not reduce any risk out of these four. Accepting the risk means that once you have identified it, you take no action. You simply accept that it might happen and decide to deal with it if it does. It is a good strategy to use when risk is small and not frequent. Risks that will not have much of…[Read more]
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Dhairya Parekh replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
I have had the opportunity to work on risk analysis at the company that I worked for in past. The risks were given numerical values based on three categories and the total risk was the product of these categories. It really depends on how the company sets up their risk analysis structure and “risk value.” It also comes back to the decision of the…[Read more]
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Dhairya Parekh started the topic Manage Risk in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Creating a list of risk is a good starting point, however, it is not enough on itself. You also need an action plan for each risk in order to be able to manage them effectively.
We learned about the standard way to manage risk in this weeks lecture:
Avoidance
Mitigation
Acceptance
Transference
Which option would you choose for low severity and…[Read more] - Load More