Rules are to be properly formed. It is good that they don’t need to give a gift that would be out of education. But there is no necessity in keeping the limits. When it comes to education it must a worthy enough constructive one. Or high limits must be set for the amount. Also there is nothing wrong in spending for a meal. I feel that the rules…[Read more]

Depending upon the states even the law enforcement differs. Each and every state has its own policies with Non Compete enforcement. The court expects a valid reason for this. If the entire business or part of it is getting some issues then they can consider the situation. I don’t think there will be a major issues with respect to changing a job…[Read more]

I worked on a collaborative project between a biometrics firm and a computer vision laboratory. Most of the R&D work was done by the lab. My project manager had a tough time working with the lab as they were very slow in their process and we had to change our timelines several times. The reason behind it was that the Ph.D. students were…[Read more]

In total agreeance with Adrian and amandaally1029. I also believe that the process of collaboration and working environment matters a lot than the organizational structure of the company. However, it is a priority for any company to choose an organizational structure for the project to run efficiently. Certainly, the matrix structure is an…[Read more]

I believe that the strategy is to manage resources based on needs and good planning as well. However, I agree with sa596’s answer. If the project manager has good communication with other department and functional manager understands needs, then the matrix organizational structure is the best-suited structure for many companies. Even though…[Read more]

Acceptance can be done for low severity risks because since the risks are low accepting and taking chances to get the benefits would be good. Avoidance and mitigation is good for high severity risks because since risks are too high and can cause potential harm to patients its better to avoid them or to eliminate them. Transferance can be done for…[Read more]

Instructions, labelling a medical device try to tell the users how to use or operate the product. So it is important that users read them carefully. To make sure that users follow the instructions, companies can do some training sessions where in they tell about how to use the product and also explain the risks associated with them when not used…[Read more]

Risk analysis, risk identification should be done at all points in the product develepoment. It should not be considered as separate task that should be done at the end stage of the product development. And also risk analysis should continue even afer the product is released in the market. This gives better feedback about the product to the company.

Device like thermometer, gauze piece, micropores are used outside the body. Only verification and validation is sufficient for these devices and clinical/preclinical trials are not needed. These devices are low risk devices which does not harm patients.

Gantt chart is very important which defines the rough time of project execution and also documents the outlines involved in the process. It is a schedule that helps to plan, record/document and track specific tasks in a project. It should invovle the individual steps like planning, designing, developing, manufacturing, quality control, budget…[Read more]

I feel all the steps in DDP is equally important.It is difficult to say which one them has more weightage than the rest. Communication management plan helps us communicate with people involved in the project. Quality management plan helps us meet quality standards of the product set by FDA. Both are equally important to have a successfful medical device.