These certifications are definitely useful in building your resume and marketability. Employers will be more keen in hiring someone with more project management knowledge and experience. The Google PMP is a newer certificate available on a more broad scale to…   Read more»

Efficient change management while meeting strict compliance standards can be achieved by implementing a structured framework that categorizes changes based on their impact and complexity. Establishing a clear documentation and tracking system ensures traceability and compliance. Utilizing electronic systems with…   Read more»

I agree that Gantt Charts and work breakdown structures are essential for visualizing project timelines and ensuring that tasks are appropriately sequenced and managed. Integrating these tools with project performance domains can enhance their effectiveness by ensuring that project processes…   Read more»

I agree that schedule risks are the most prevalent in many projects due to the numerous factors that can impact timelines, such as inaccurate estimates, communication delays, and unforeseen issues. However, quality risks are indeed the most devastating, especially in…   Read more»

The work breakdown structure in processes and deliverables occurs after establishing the planning phase by sequence for developing a medical device that can follow design controls. Design controls refer to the systematic process used to manage the design, development, and…   Read more»

@sn64 Hey! The first step would be to establish a framework, defining a clear tiered approach to classify the changes. Then I would ensure that there is a clear documentation and tracking system in place to ensure proper documentation and…   Read more»

I believe the most present risk in the majority of projects would have to be a schedule risk. This is because of the immense number of factors that can all affect the schedule of the project at any given moment….   Read more»

Hello! My name is Sean Caswell and I am doing my master’s in BME at NJIT! I look forward to connecting with you all!
Here is my LinkedIn -> Sean Caswell | LinkedIn

In practice, the scale, time required, and procedures differ considerably among Non-essential Design Changes, Design Change Numbers, and Engineering Change Orders (ECOs). Non-essential Design Changes usually involve minor adjustments that don’t significantly impact performance or regulatory compliance. These can often…   Read more»

Keeping up with regulatory trends is an evolving process that requires constant engagement with industry news, conferences, and professional networks. In my experience, staying informed involves subscribing to updates from key regulatory bodies like the FDA, EMA, and other regional…   Read more»

The debate over certification validity often comes down to what specific skills and frameworks you need in your career. Google PMP, is a relatively new credential that emphasizes practical, agile, and digital project management skills designed for modern, fast-paced environments….   Read more»

@sarahqudah1 I believe that with medical device projects, market adoption is one of the more overlooked issues. Cost and accessibility of the product are important to consider in the creation of it. High development costs create high costs of product,…   Read more»

Slack is important in case a part of a project is not going according to plan and time is needed to find the issue and deal with it. This can be the result of a variety of issues, including factors…   Read more»

Especially in terms of medical device development, early start and finish dates allow for flexibility in schedule that can be incredibly helpful based on issues occurring with the project. Issues with ordered resources, delayed meetings, and problems with deliverables can…   Read more»

Quality risk is the most overarching type of risk as a product or process needs to meet every requirement listed in the project which might take several prototypes to create a comprehensive device. In addition, that device would then to…   Read more»

Hi,I’m a student at NJIT in the biomedical engineering program.https://www.linkedin.com/in/michael-m-a97aa21ab/

Scope management directly influences the cost and time management of a project. As the scope increases, it comes with the expense of a higher cost (usually). Increasing scope can also alter the timeline in a way that is not beneficial…   Read more»

I think your ranking makes a lot of sense, especially with SOPs being the easiest to change and anything after the design control phase being more complicated. SOPs are mostly procedural, so updating them is usually pretty straightforward since they…   Read more»