Design verification is important for ensuring the success of a medical device. It demonstrates that the product is safe ,designed correctly and design input meets design output. Design verification sh...

The project closing phase is as significant and impactful as the Initiation, Planning, Executing, and Monitoring and Controlling phase. The impact of project closing can be extensive, both to the proj...

A risk management team is a separate and often independent unit within the project management team headed by the risk manager .The team also develops strategies to mitigate identified risks, applies r...

The Planning/Initiation phase sets the foundation for the other phases. The execution phase is also an important part of project . Being the longest phase of project because there are three primary st...

The unresponsive team member’s communication delays the entire project or causes the organization to miss opportunities. Decisions may be delayed and delayed meetings disrupt project schedules . Howev...

One of the challenge that the project manager can face is enabling leadership in other. Team members are more calm and focused when they are in charge of their own work and not under the constantly ev...

Accurate time estimation is essential for a good project management. Sometimes project manager fails to estimate correct time due to unexpected events or unscheduled high priority works or may be unfa...

Missing a milestone leads to failure of a project. Milestones can be used to determine the success of your project and super effective way to manage multiple projects at the same time effectively. All...

There are various success factors for a project like smart people in the team,smart planning, careful risk management,clearly defined plans and open communication . Clear planning is an important par...

Design Validation is a Design Controls activity that happens late in the product development .This is the stage where you actually build a version of the product and validate against the user requirem...

Risk is the function of seriousness of the harm and probability that will occur . The risk can be physical,social,physiocologlcal, Economic. The risk-benefit ratio is a comparison between the risks o...

Combination products are assigned to Centers with primary jurisdiction for premarket reviews and regulation. The determination is based on “primary mode of action” of the combination product. Sponsors...

Design transfer is a complex process involves transfer an approved design into production. Every manufacturer should follow procedure to ensure that design is correctly transfer into production specif...

Change control is a procedure for ensuring that changes to any product within scope of quality management system are planned, approved and implemented in a controlled manner maintaining safety and eff...

The project manager is mainly involved in the early stage of a project and ensuring that the company have a clear understanding of client's goals and desires outcomes. Project manager has to perform t...