The monitoring and control process of the project management consists of the activities involved to observe the process after project implementation, identify problems and risk, and deploy a mitigation strategy to control the new process. Monitoring and Controlling project work…   Read more»

Metrics permit organizations to measure its performance against industry sectors to determine how well the company is doing. Metrics help transform the vague requirements that a customer gives into a series of numbers that can be used to accurately map…   Read more»

Combination products are medical products that combine a drug, device and/or biological product. in order to ensure efficient review, a single application is generally appropriate for combination products. FDA provides a structured framework for evaluating combination products, considering both device…   Read more»

The executing process refers to any specific point during the activity or project as a whole in which  the act of executing takes place, and the predetermined processes of getting to that point of accomplishing that action successfully. Project execution…   Read more»

Scope management is the process of defining what work is required and then making sure all of that work. scope management plan should include the detailed process of scope determination, its management, and its control. In project management, scope is…   Read more»

A risk management team is a separate and often independent unit within the project management team headed by the risk manager or the chief risk officer. It helps place a value on the projects activities . The  role of a…   Read more»

The purpose of customer input is to translate the customer requirements. Customer inputs is usually garnered via surveys and complaints. Customer involvement entails engaging customer in a two- way iterative conversation using a variety of mediums including focus group, surveys,…   Read more»

Preplanning is the review of planned operations before and during construction in order to identify and eliminate potential loss. The goal of preplanning is to reduce hazards, which will minimize disruption, increase efficiency, and lower costs. Pre-operational safety planning involves…   Read more»

Successful team development involves great leadership and support at every stage of the process. It is important for team leaders to facilitate the introductions and highlight each persons skills and background. Team member are also given project details and the…   Read more»

There are lots of project management success factors that play a role in a project successful. A project manager should endeavor to elicit commitment from the team members, clients, top management and all stakeholders. A project management should ensure that…   Read more»

Design change request is a formal proposal for an alteration to some product or system. In project management, a change request often arises when the client wants an addition or alteration to the agreed upon deliverables for a project. The…   Read more»

Project execution is the phase in which the plan designed in the prior phases of the project life cycle is put into action. The purpose of project execution is to deliver the project expected results. Is to develop and produce…   Read more»

The closing phase of project management is the final phase of the project lifecycle. This is the stage where all deliverables are finalized and formally transferred, and all document is signed off, approved, and archived. The primary objective of the…   Read more»

A Gantt chart is a type of bar chart that illustrates a project schedule. This chart list the tasks to be performed on the vertical axis, and time intervals on the horizontal axis. Gantt charts are usually created initially using…   Read more»

 Design validation is one of the most important aspects of the design and development process for medical devices. Design Validation is a testing process by which you prove validate that the device works for the end user as intended. official…   Read more»

Risk management involves the identification, understand, control, and prevent failures that can result in hazards when people use medical devices. Risk analysis plays a key role in the development of medical devices. Risk management is necessary to ensure device usability,…   Read more»

The planning phase is when the project plans are documented, the project deliverables and requirements are defined, and the project schedule is created. It involves creating a set of plans to help the project team through the implementation and closure…   Read more»

Monitoring is checking the progress of the project to ensure compliance with project scope, timelines, deliverables and schedules. Project control is measuring such progress by comparing and contrasting actual progress with project plans and schedules and taking corrective action as…   Read more»

A risk management team is a separate and often independent unit within the project management team headed by the risk manager or the chief risk officer. The role of a risk manager is to communicate risk policies and processes for…   Read more»

One of the most important aspects of a project manager job is measuring progress of the project on each task. It helps employees stay focused. There are some steps that help to measure project progress:  – Tracking tasks   -…   Read more»