A significant mistake in project planning is to assume full availability of all the team members. The management has the right to rearrange the employee vacation schedule to meet the deadlines. in the absence of a team member the project should not suffer so the PM should discuss with team members the plan in advance to avoid the conflicts and…[Read more]

The process of identification and evaluating risks starts in the planning phase of the project and continues through out the project. It is important to determine each risk likelihood to occurring as well as its effect on the overall project .The earlier the risks can be identified, earlier plans can be made to mitigate risks. Qualitative risk…[Read more]

Risk is when an uncertain event or condition can occur and have an effect on the project outcome. Project manager tries to know everything about risks so that it could not effect negatively to the project. Project managers know how to mitigate risk, and use it as a core strategy in project management. PM will documenting risks and note where i…[Read more]

For any medical device manufacturer an FDA audit is a necessary and a potentially difficult part. The company should maintains proper documentation . The updated documents like DHF,DMR and dozens of other demonstrates the commitment to quality , accuracy and thoroughness. When the work is properly logged and updated documents one could easily…[Read more]

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 should start at an early stage when design input are developed. If process of proving that medical device is correctly designed starts at an early…[Read more]

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 project and to the organization. The key benefits of this process are the project or phase information is archived, the planned work is completed, and…[Read more]

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 risk management methodologies and risk analysis tools, and integrates insurance policies of treating prioritized threats with the project management…[Read more]

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 steps include building the deliverables, monitor and control, and review. In this phase progress is continuously monitored and appropriate adjustments…[Read more]

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 . However chasing people for responses distracts people from more productive work. In case there is an irresponsive team member the ideal first course o…[Read more]

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 boss. Enabling leadership only happens when team members clearly understand expectations, have the skills, knowledge and ability…[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 time project manager should identify all the work need to be done within a project and how much…[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 and they should clearly identify what needs to be achieved . The project lifecycle is most likely…[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 with enough detail so that everyone involved knows where the project is going. A good 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 one step or multiple steps of the process, usually in stages and is used to determine if the…[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 figure out whether the risk or benefit is most significant. Every medical procedure has risks…[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 can petition the OCP to assign its product to a review center through a Reque…[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 create and maintain documents necessary for design transfer. The…[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 will go for letter-to-file or a special PMA/510(K) supplement. Letter-to-file remains internal…[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 , resource allocation, risk assessment. The project manager has to be plan all activity necessary for the…[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 team must be informed about their role in project and they must be informed about the a…[Read more]