In school, research, and at work, communication is the biggest common denominator that dictates success. Email, text, google hangouts, GroupMe, and Slack is what I typically use across all three to set up an open line of communication with a…   Read more»

I have never used a Pert chart but like @mmd55, I have created a Gantt chart before. Personally, I believe I would prefer a Gantt chart because for large projects where there are several tasks a Pert chart could get…   Read more»

Investors usually have expectations in terms of how they want the resources they are providing to be used and it is the managers responsibility to make sure that they coordinate with the team in order to meet those expectations and…   Read more»

I had some experience with this during my senior Capstone, where we had to create a Gantt chart to map the critical paths for completing our project. In task scheduling, early start is the soonest date you can begin any…   Read more»

I agree with @mmd55, in that this discussion does boil down to what we prefer, either working for a startup/small and medium enterprise (SME) or a large company. I am currently working in both and would once again have to…   Read more»

The FDA had issued an Emergency Use Authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 Vaccine, the Moderna COVID-19 Vaccine, and the Janssen COVID-19 Vaccine given the pandemic level health crisis. Nevertheless, the FDA still performed their due diligence…   Read more»

At my job I have been working on securing the PACs server for a set of new ultrasound units, however, the department who made the request is asking to have the studies sent to a server they have never used…   Read more»

I believe individuals should work on separate parts and that smaller groups should gradually form within the team before the product is finalized as an entire team. I agree with @anthonynjit in that every successful group understands the importance of…   Read more»

Design verification is where the manufacturers develop procedures to verify the device design – meaning confirming that the design outputs (reference criteria and evaluate device for proper functioning) meet the design inputs (complete, clear, and non-conflicting requirements relating to the…   Read more»

I believe this perspective depends on multiple factors such as what field you are in, position/role, or the size of the company. If we focus specifically on life in industry where there are consumers and users; according to the PMI…   Read more»

During projects in and out of the classroom, I have typically assumed both roles. I enjoy being hands on, using my technical knowledge, and working on aspects of a project but also like to plan and coordinate with others on…   Read more»

Design verification is one of the nine design controls which is a phase where each manufacturer establish clear, complete, and unambiguous procedures during the actual development, as oppose to after as in the case of the validation control, to verify…   Read more»

As mentioned in the lecture there are nine design controls listed in 21 CFR 820.30 – these include: planning, input, output, review, verification, validation, transfer, design changes, and design history files. As stated by @mmd55, all nine parts are essential…   Read more»

I believe the most important FDA responsibility as mentioned by my peers is advancing public health by expediting innovation, hence the case, with companies such as Pfizer-BioNTech receiving emergency use authorization by the FDA for the COVID-19 vaccine. However, prior…   Read more»

To clarify from my original post, I would think as per the conditions listed by the FDA for what devices qualify as a Class 2 device and what prohibits devices from filing a 510(k) as per the post from @anthonynjit,…   Read more»

Thank you @wonbum-sohn for creating this post and for everyone who has responded. As mentioned in other threads, I am working on a point of care device for early cancer screening. Although the targeted biomarker of interest for the device…   Read more»

I have never worked in regulatory affairs, however, my understanding is that it is an essential segment of every industry, let alone the medical device industry. An individual working in regulatory affairs is responsible for overseeing product development, testing, manufacturing,…   Read more»

Hello everyone! I know for week 1 we were only asked to read through chapter 1 of the PMBOK Guide and information on organizational structures is in chapter 2, section 4.4 but I still wanted to respond to this post…   Read more»

To answer this question, let’s first define a program. A program is a group of related projects that are managed by a team as opposed to an individual. Therefore, as per chapter 1, section 2.3.2 in the PMBOK Guide, programs…   Read more»

It is interesting how everyone has reflected back on their days in senior capstone, which is a perfect example of a project – a temporary endeavor to create a unique product/service that drives change and enables business value creation. It…   Read more»