-
jla33 replied to the topic "Challenges PM face" – 5 years, 11 months ago
The first major challenge that project managers and team members might face is not knowing what exactly to expect from the project. If the goals and objectives are not clearly defined, the project is doomed to fail. When no one… Read more»
-
jla33 replied to the topic "Best timing for validation and verification" – 5 years, 11 months ago
Verification and validation process covers all phases of product development and different many technologies. I think it is extremely important to consider this process early in the design stage when developing the requirement specifications for the product or the medical… Read more»
-
jla33 replied to the topic "Unapproved Device" – 5 years, 11 months ago
I think in general, an unapproved medical device can be used on only human subjects when the device is under some clinical investigation and when it is used by some investigators participating in a clinical trial. (1) However, there may… Read more»
-
jla33 replied to the topic "Project management team" – 5 years, 11 months ago
For a project to be successful, team members should be chosen very wisely. While some leaders choose people based on their knowledge or area of prior experience, it is not necessarily the best way to do so. There are some… Read more»
-
jla33 replied to the topic "What is Risk Management Plan?" – 5 years, 11 months ago
If I have a project to finish by a specific due date or an exam to study for, taking remedial measures at the very beginning of my work will help give a head-start as well as avoiding any issue that… Read more»
-
jla33 replied to the topic "Interpersonal skills vs technical knowledge" – 5 years, 11 months ago
In my opinion, this is a proper investment to some extension. The things that can differentiate between two engineers are their interpersonal skills. The technical knowledge, which is %30, is very important because this is the factor that could make… Read more»
-
jla33 replied to the topic How to make good relation with vendors in the forum Project Management Application: Clinical Trial 5 years, 11 months ago
The first step to nurturing an effective business relationship is by establishing and maintaining a connection. This means that you should be in touch with vendors regularly. If at all possible, meet in person at your office so that vendors can get a better feel for your business, and visit their offices as well. Share your goals with vendors and…[Read more]
-
jla33 replied to the topic Priorities for Projects in the forum Project Management Application: Clinical Trial 5 years, 11 months ago
In my opinion, I think it is possible to have multiple objectives or goals for one project. It is very important to identify the scopes of the project before hand to make sure these different goals or priorities are put into consideration. However, widening the scope of the project to include more activities can increase how much needs to be done…[Read more]
-
jla33 replied to the topic How was this class helpful in the forum Project Management Application: Clinical Trial 5 years, 11 months ago
I have learned a lot about project management techniques and methods related to medical devices and practical problem solving simulations based on real-world examples of medical device projects. I learned how to work in a team on a commercial medical device projects and the project management processes and all the PM knowledge areas applied to…[Read more]
-
jla33 replied to the topic Things to look for in a contract while selecting a supplier in the forum Project Management Knowledge Areas 5 years, 12 months ago
I agree with the above replies, as medical devices become increasingly complex, the need for reliable, compliant, and cost-efficient supplier partners is of great importance to strategic sourcing and direct procurement executives. At the center of all decision-making is balancing quality and cost when finding and partnering innovative suppliers.
5…[Read more] -
jla33 replied to the topic Six Sigma and Project Management in the forum Project Management Knowledge Areas 5 years, 12 months ago
The Six Sigma offers a structured and disciplined process for solving business problems. Six Sigma uses tools designed to identify root causes for the defects in processes that keep an organization from providing its customers with the consistent quality of products the customers requirements on time and at the most reasonable cost. The Six Sigma…[Read more]
-
jla33 replied to the topic QA vs QC in the forum Project Management Knowledge Areas 5 years, 12 months ago
Quality assurance is a set of different activities for ensuring the quality in the processes by which products are developed. It aims at preventing defects with a focus on the process, which is used to make the product. It is a proactive quality process. The main goal of QA is the improvement of the development and the testing processes. It…[Read more]
-
jla33 replied to the topic Team Development in the forum Project Management Process and Medical Device Development 6 years ago
While employee absenteeism due to illness or other issues is an unavoidable fact of life, there are many measures that managers and employers can take to minimize employee absenteeism and to better manage it in general. Although employee absenteeism is an issue for any business that employs workers, many managers and employers fail to institute a…[Read more]
-
jla33 replied to the topic Sucess Factors in the forum Project Management Process and Medical Device Development 6 years ago
I think you have pointed out the most important factors for project success. Communication comes as the most important out of all of them. Communications should be well defined and efficient in order to prevent delays. Each member of the team should be prompt in their availability and their fast responses when needed. Defined plans are always…[Read more]
-
jla33 replied to the topic Project budget and variance in the forum Project Management Process and Medical Device Development 6 years ago
Earned Value Management (EVM) is a technique that can be used to measure project performance against the project baseline. This technique can be considered by insight to be one of the best practices areas for monitoring project performance from both a cost and schedule perspective. It is always important to think about two things, ahead of…[Read more]
-
jla33 replied to the topic Factors affect schedule variance (SV) in the forum Project Management Process and Medical Device Development 6 years ago
It is imperative to keep the project on a schedule not only to finish it on time but also to enable unnecessary cost overruns to slippage of schedule because the costs start rising exponentially. Schedule variance is a vital analytical tool for project management. This tool can give all the information needed to determine if we are ahead of…[Read more]
-
jla33 replied to the topic Executing Process in the forum Project Management Process and Medical Device Development 6 years ago
I personally disagree with this statement. I do not think these are the most important parts of the entire project; they are still very important aspects of the execution phase of the project. When it comes to the execution phase of the project there are several ways of succeeding in terms of developing and completing deliverables. The executing…[Read more]
-
jla33 replied to the topic Overlapping activities in the forum Project Management Process and Medical Device Development 6 years ago
3The planning stage plays an important role in helping guide stakeholders, sponsors, teams, and the project manager through all the other project phases. Planning is essential to identify the desired goals to reduce risks, avoid missed deadlines, and ultimately deliver the agreed product or the result. Without careful planning and good planning…[Read more]
-
jla33 replied to the topic Estimating Project Timeline in the forum Project Management Process and Medical Device Development 6 years ago
For the project manager to come up with an ideal time for each task has to come after research on this specific task and then answer some questions like if this has been done before and if yes how long did it take, ask some people who have done something similar to see what could be an appropriate time frame for this specific task, or maybe ask…[Read more]
-
jla33 replied to the topic Inputs for Design Input Document in the forum Project Management Process and Medical Device Development 6 years ago
Defining requirements of a medical product early in the process is very important to prevent some costly revisions later and any delayed time to market. Key to success of the medical device is to take into consideration the total product life cycle. The research and development team (R&D), the quality team, marketing team, regulatory, and industry…[Read more]
- Load More