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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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….   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…   Read more»

Design control is a formal methodology to conduct the product development activities. It is mandatory to implement such practice when designing and developing products within regulated industries like medical device. It is important because the product designed should be safe…   Read more»

Design control is a formal methodology to conduct the product development activities. It is mandatory to implement such practice when designing and developing products within regulated industries like medical devices. Design control is one of the most important thing in…   Read more»

Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a placebo treatment which is specifically designed to have…   Read more»