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gp232@njit.edu replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 8 years, 3 months ago
Although it may sound easy to recommend an agreement be written versus oral, sometimes time does not allow this to happen and does not allow every agreed upon aspect included in the contract. For instance, when a quick decision needs to be made an oral agreement may suffice. However, if details are left out for any reason, both parties will have…[Read more]
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gp232@njit.edu replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies 8 years, 3 months ago
In response to the first post, I believe it is better for teams to work with people who are knowledgeable in their department roles. I would avoid assigning people to teams who I know have a bad history together. In this case, it would be better to avoid conflict by placing a couple of people who work well together with others who are…[Read more]
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gp232@njit.edu replied to the topic Organizational structure and Culture both leading to project success? in the forum Organizational Development in Device Companies 8 years, 3 months ago
I have to disagree with the first post that organizational culture plays a significant role in the creation of work environment, ethics, and the view of authority. I believe the best teams can be established however; without proper leadership and organizational behavior boundaries, projects can fail. Attitudes and ethics play a large role in the…[Read more]
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gp232@njit.edu replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies 8 years, 3 months ago
Several factors impact organizational performance such as culture, motivation, decision making, and change management. Each of these factors impact organizational behavior differently. I would say one of the most impactful factors is change management. People hate change and when you introduce something new to their daily routine, they can…[Read more]
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gp232@njit.edu replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 8 years, 3 months ago
I agree that risk management is a “checkbox” activity to some companies. Just like quality control and quality assurance, risk management is important to producing a safe product built of high quality. I believe there is a point where a product design reaches a limit, however if the safety or quality of a product can be improved upon without add…[Read more]
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gp232@njit.edu replied to the topic Risk Management – Identification in the forum Risk Analysis for Medical Devices 8 years, 3 months ago
I identify risks from high to low and everything in between. I believe managing risk is a balancing act which takes time and skill to master. What you may not perceive is a high risk and miss-categorize it as a low or medium risk, could come back to bite you later on in the project. Risk avoidance or putting a risk off during each phase of a…[Read more]
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gp232@njit.edu replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 8 years, 3 months ago
Dhairya,
For low severity of risk I would choose acceptance. If a risk is acceptable, it should be low by default. High risk items should be mitigated down to a medium or low risk whenever possible. I don’t think avoidance reduces the risk level out of the severity of a risk. I view avoidance as brushing something under the rug and hoping i…[Read more]
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gp232@njit.edu replied to the topic Minutes for meetings in the forum Introduction to Design Controls 8 years, 3 months ago
Roberto,
Meeting minutes may not seem important until you need them. In one case, I was in a meeting where I was aware of what was said and agreed to but did not remember the specific date and person who made an agreement to something. I sorted through emails until I found the set of meeting minutes that would allow me to justify calling…[Read more]
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gp232@njit.edu replied to the topic Design Review Meetings in the forum Introduction to Design Controls 8 years, 3 months ago
Himang,
I don’t have personal experience with design review meetings however; I have a friend who has some experience in such meetings. The design review process itself could happen in stages. As you mentioned, a design review could last hours to weeks depending on the complexity of the project and interests of the stakeholders involved. A g…[Read more]
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gp232@njit.edu replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls 8 years, 3 months ago
Design controls may not be required for Europe, however they can come in very handy with the Design Dossier or Technical File. Logging the development process is good practice and should be done regardless if it is required. If the company is US based and starting up an office or sub-company in Europe, it would be wise to adapt to the European…[Read more]