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 evaluative eye of a…   Read more»

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 unfamiliar with the type of task . For estimating correct…   Read more»

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 milestones should be specific and measurable…   Read more»

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 part of project success . All projects must have a plan…   Read more»

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 requirements. The process of validation generally occurs as…   Read more»

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 of a situation and its benefits. The goal is to…   Read more»

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 can determine their product’s PMOA, If the PMOA is unclear, a sponsor…   Read more»

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 specification. Sometime the product team doesn’t understand or don’t have enough time to…   Read more»

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 efficacy of the product. The company have to decide they…   Read more»

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 the task related to timelines, budget ,…   Read more»

The matrix structure allows an efficient use of company’s resources. There could be some negative impact on project due to conflict between project manager and functional manager. The most difficult challenge in matrix form is team development. Every member in…   Read more»

The different stages of project includes initiation, planning ,execution ,managing and control , closing. In the initiation phase of a project ,the project meeting are quite important which states the roles and responsibilities of individual working on the project it…   Read more»

Interpersonal skills are as important as technical knowledge .Interpersonal skills are the way to how someone relate and communicate with other. Interpersonal skills are attributes that are used to motivates employees and how to make them use their knowledge to…   Read more»

The risk management plan is a document prepared by project manager to foresee risks and methods to either minimize or eliminate their negative impact on project . An ideal risk management plan can solve any unexpected problem coming while executing…   Read more»

When bringing a medical device into market company will determine whether to submit 510(K) or PMA. If the company could not make right decision getting unsafe product in customer’s hands causes serious damage and product failure. The class II devices…   Read more»

The company should invest in the project if it is making steps in right direction. Not every idea has the potential to turn into a viable business. Great idea needs to solve specific kind of a problem in order to…   Read more»

The efficiency and outcomes of a project directly depends on the team who work on the project. However assembling right people for team is a critical task. For a successful project, the requirement of a project should be deeply understand…   Read more»

A Quality Plan clearly defines what the quality management system is supposed to achieve. Quality planning means that you are going to make a device according to the project plan . Beside the project is completed on time and in…   Read more»

The project manager for medical device company leads the team of engineer ,owns the relationship with clients and applying engineering knowledge to ensure successful outcomes . Assembling a medication reconciliation team is an important task for project manager for medical…   Read more»

When a physician uses unapproved medical devices it risks the safety and health of patients. Such medical devices should not be available during regular clinical care. FDA recognizes the emergency use of a investigational devices in a immediate life threating…   Read more»