Medical devices are regulated by the us food and drug administration (FDA), there is a specialized division names Center for Devices and Radiological Health (CDRH) which reviews device application and monitors the safety of the medical device sold. The devices are classified on the basis of the risks possess to patients and the users. There are…[Read more]

I think selecting a proper project team is very important because it affects the performance and the outcome of the whole project. The members should have skills that are needed for the project for its successful completion. There is necessity of having a friendly environment in the team since that can build the team or it make break it. The team…[Read more]

It depends on the risks involved and the rewards of the project idea. How much funding is needed how much is the potential for the success also the time frame of the completion of the project idea. If the project has better benefits and improves the life, then in my opinion dropping the project is not a good idea if the project idea is beneficial…[Read more]

To succeed the project managers should be good at planning as it is one of the most important skill to accomplish the project in a systematic way. Planning helps how the project should be executed, monitored and controlled. Another skill required is the resource management which include which team member is going to work on which task to enable…[Read more]

I think the label and the information on the product is very important for the patient as patients normally read it carefully before consuming it or using it. So, I think it is better to recall the product from the market because the missing information or the error in the label may be important to the patients who are going to use it. Since both…[Read more]

Most of the hospitals and doctors uses FDA approved devices. I don’t think such situation can happen. From the FDA perspective it approves the drug, products before it is used by doctors. If these devices are helping to cure any disease it should be properly tested and should be approved by the FDA before its use on the patients. But in case of t…[Read more]

I believe that Project manager should have leadership qualities as they must manage teams having vison, motivating the team members, inspiring them, resolving conflicts. Leadership in project manager means providing vison and roadmap for success and encouraging the team to lead to the success. Another skill that a project manager should have is…[Read more]

Non-Disclosure agreement is a legal contract between at least two parties that outlines confidential material, information that wish to share with one another for certain purposes but jot the third party. It is also create confidential relationship between the parties to protect any type of confidential and proprietary information. It protects…[Read more]

Oral contract is formed by verbal agreement like word of mouth and comes about when two people speak to each other. Written agreement assures that both the parties know the exact terms of the contract and provide proof of the agreement. It is better to have a written agreement since there are less chances of understanding about the terms and…[Read more]

Sir, this is my first online class in master program and it was new experience as I never had such learning experience before. I was not sure about the opportunities about various profile in the market but after studying the subject I learnt about various opportunities. Project is giving another new learning experience and able to interact with…[Read more]

I think working with matrix organization structure would be more challenging and complicated. Matrix organization structure is a combination of two or more types of organizational structures. The major disadvantages are monitoring and controlling as complexity increases from the number of managers involved. There is more complexity in the…[Read more]

The choice of the structure depends on the size of the company, the way the organization is structured influence to manage and run the project. I think functional structure organization is a common type of organization structure where the team members work for the specific department such as engineering, human resource, Information technology. In…[Read more]

The main aim of project is to accomplish the goal of the project by completing it successfully. In a company when working with people you may know would be easy as compared to work with strangers since you know them well before hand. I would prefer to work with people who have more knowledge and experience in their departmental roles. It’s a g…[Read more]

A risk-benefit analysis is a comparison between the risks of a situation and its benefits. Risk Benefit Analysis is important to determine the benefits and risks which are considered for the product. The main aim is to find out if the risk or benefits is significant. It is often used in medicines since every medical procedure has risks associated…[Read more]

In medical device industry, labelling is important as it helps the manufacturer to meet the requirement of the device also helps customer in clinical setting to how to identify the devices. It is important that doctors to have training in operating the medical device. Doctors prescribing the medicines to the patient would intake the medicines…[Read more]

I agree with the error that risk management is not a life cycle process because it is not something which is at the last step instead it should be a continues process throughout the development of the device. Risk analysis meeting is important it is more than one meeting. Risk should not be relying on the historical data. Risk manager has to…[Read more]

Minutes also known as minutes of meeting are the informal notes are the instant written records. It describes the events of the meetings and includes list of attendees, statement of issues considered by the participants, and related responses or the decisions for the issues. The purpose of meetings includes an official written record of the…[Read more]

Glove liners or under gloves are worn with patient examination or surgeon’s gloves which are made of material such as cotton to prevent the medical glove from contacting the user’s hand or may be made of the material that are resistant to cutting or puncture. Medical devices such as crutch which is used as a mobility aid that transfers weight fro…[Read more]

A design specification document (DSD)is a detailed document which provides information about a designed product or process. For example, the design specification must include all necessary drawings, dimensions, environmental factors, ergonomic factors, aesthetic factors, maintenance that will be needed, etc. It may also give specific examples of…[Read more]

Verification is a proof that the designed product is correct. Design verification demonstrates that the medical device design output meets the design input. Verification is all the inspection, measurement, analysis and testing that one has the correct output specification relative to the design input requirements. Verification is less about…[Read more]