Medical Device Courses | 31470977 | Activity

31470977 replied to the topic "Procurement Management" -

Mon, 20 Apr 2026 02:20:02 -0400

After reading over many other responses here, I believe the general consensus is no, but I am willing to play devil’s advocate and say that sometimes yes, a company may want to prioritize cost savings over supplier diversity in some… Read more»

31470977 replied to the topic "Importance of Human Resource Management" -

Mon, 20 Apr 2026 02:04:58 -0400

HR here works as a way to improve the quality of people that enter a company which can help in better device designs and smoother project completions. Essentially, there needs to be a filter for quality when it comes to… Read more»

31470977 replied to the topic "Things to look for in a contract while selecting a supplier" -

Mon, 20 Apr 2026 01:55:53 -0400

After pondering this situation, five things come to mind: 1. Pricing and Overall Total Cost This is important as the initial cost may seem favorable but looking at terms can unlock hidden fees. After factoring all costs listed in the… Read more»

31470977 replied to the topic "Verification Protocols vs. Reports" -

Mon, 13 Apr 2026 00:26:22 -0400

Verification protocols are guidelines that explain how verification is done. They include procedures, criteria, test methods, and standards and are generally established before execution. These protocols help guide the team on what steps are to follow. Verification reports on the… Read more»

31470977 replied to the topic "Making connections between people and schools" -

Mon, 13 Apr 2026 00:11:34 -0400

http://www.linkedin.com/in/vincent-prado-6628a8303
Hello Everyone! Attached is my LinkedIn profile. It’d be great to connect! Looking forward to meeting you.

31470977 replied to the topic "Difficulty of a Project" -

Sun, 12 Apr 2026 22:39:57 -0400

In my opinion, “handling people” is the biggest challenge when it comes to working on a project. Every single person is different as one can be working with amazing teammates who are responsive, attentive, and willing to work and communicate… Read more»

31470977 replied to the topic "Difficulty of a Project" -

Sun, 12 Apr 2026 22:39:50 -0400

31470977 replied to the topic "Different results from each test companies." -

Mon, 30 Mar 2026 01:28:06 -0400

The company has to re-run the tests to determine who has the correct results. Once this is done, they have to compare testing methods and view what standards are being used. Afterwards, they look to fix the issue whether it… Read more»

31470977 replied to the topic "Project plans flexibility" -

Mon, 30 Mar 2026 01:20:53 -0400

In my opinion, I believe that having a plan that seems rigid and can be followed is ideal, but this plan has to be able to be modified in case anything happens. What this means, I suppose, is a flexible… Read more»

31470977 replied to the topic "Power of Stakeholders" -

Mon, 30 Mar 2026 01:15:58 -0400

Stakeholders have very high influence when it comes to shaping a project because projects are done through requirements, funding, and approvals which are all things that stakeholders hold control over. With this power, they are able to define objectives such… Read more»

31470977 replied to the topic "project changes and stakeholders" -

Fri, 13 Mar 2026 05:11:17 -0400

First there needs to be an impact analysis on the scope, schedule, cost, and risk to the project. Doing this allows one to ascertain changes to the original project baseline and then one must identify new risks caused by this… Read more»

31470977 replied to the topic "Design Transfer" -

Fri, 13 Mar 2026 05:04:25 -0400

Some of these aspects I had to do during my previous internship as I had to hand off my project to the following intern who would pick up where I left off. Documentation and knowledge transfer is an important factor… Read more»

31470977 replied to the topic "Lessons Learned" -

Fri, 13 Mar 2026 04:47:12 -0400

Reporting lessons is valuable in a company/project team as this could help future project teams avoid repeating the same mistakes. It can capture practical knowledge that might not appear in formal procedures. It could also offer continuous improvement within the… Read more»

31470977 replied to the topic "Importance of Stakeholders" -

Mon, 09 Mar 2026 02:11:26 -0400

In terms of promptness, a manager is far more important. Managers are hands on in control of what happens within a project. Investors provide monetary funds but tend to be mostly hands off. It is not their decisions as to… Read more»

31470977 replied to the topic "Missing a Milestone Experience" -

Mon, 09 Mar 2026 02:05:27 -0400

This happens constantly with projects that I am in. Specifically, I’ll mention my capstone project. I have limited access to the lab throughout the week, and because of this, I try to utilize my time as efficiently as possible inside… Read more»

31470977 replied to the topic "Ideal PM Processes vs. Real life" -

Mon, 09 Mar 2026 01:53:53 -0400

I feel like a lot of these phases are followed conceptually, but they could overlap one another or have different areas of importance. Sometimes planning could still continue to be done while execution already started. There is still the general… Read more»

31470977 replied to the topic "Combination Product" -

Mon, 02 Mar 2026 03:10:57 -0500

Nicotine gum is a product used by smokers to try to stop or limit smoking. It delivers doses of nicotine through the oral mucosa to help reduce smoking withdrawal symptoms The person is instructed to chew the gum intermittently to… Read more»

31470977 replied to the topic "Things help to understand project status other than project matrix" -

Mon, 02 Mar 2026 02:56:20 -0500

Three factors that can help detect the status of a project can be as follows: Milestone Completion Rate – This tracks whether milestones are being completed on schedule. This can indicate the project progress over time and show any timeline… Read more»

31470977 replied to the topic "how the PM handles budget cut?" -

Mon, 02 Mar 2026 02:46:56 -0500

I agree with the OP, working under budget may be beneficial in the long run incase of any unforeseen circumstances. However, one must not work so under budget that it affects the quality of the work. There needs to be… Read more»

31470977 replied to the topic "Email Communication" -

Mon, 23 Feb 2026 04:30:44 -0500

As a PM, one can organize their email by using folders and rules to sort through messages, set specific times in the day to respond to messages, and apply priority flags for urgent emails. They also may need to unsubscribe… Read more»

31470977 replied to the topic "Are Missed Milestones really Bad?" -

Mon, 23 Feb 2026 04:26:19 -0500

I think it is more important to determine why the milestone was missed. Sometimes milestones are missed due to unforeseen circumstances. This was the case at a previous internship that I was at. There was a problem with contamination, and… Read more»

31470977 replied to the topic "Team members personal issues with eachother" -

Mon, 23 Feb 2026 04:23:24 -0500

First and foremost, I would avoid taking sides and try to remain neutral in these situations. I also believe that it is important to listen to each person by themselves first to get an accurate idea as to how each… Read more»

31470977 replied to the topic "Difference" -

Sun, 15 Feb 2026 21:57:54 -0500

In short, a project manager is broad and can be a part of any industry. Clinical project managers on the other hand are simply a subset of project managers that are doing healthcare or clinical research specific work with regulatory… Read more»

31470977 replied to the topic "More Influence or Less?" -

Sun, 15 Feb 2026 21:47:28 -0500

To ensure efficient team member contribution, I would delegate tasks as well as deadlines to each individual as well as daily meetings. I would also offer each member the ability to have open conversation with each other. If someone finishes… Read more»

31470977 replied to the topic "Organization type preference" -

Sun, 15 Feb 2026 21:41:32 -0500

My favorite way to work is by projects so a project based organization would be awesome. I enjoy the drive and pressure that comes with doing a project. However, this does not seem to be a long term stable working… Read more»

31470977 replied to the topic "Business and customer satisfaction in project management" -

Mon, 09 Feb 2026 04:11:19 -0500

A project manager can be skillful about aligning business needs and customer satisfaction by doing many things. The project manager needs to be able to define the project scope so business goals can translate into real customer values. They need… Read more»

31470977 replied to the topic "FDA about upgraded device" -

Mon, 09 Feb 2026 04:05:21 -0500

FDA reevaluation depends on the type and impact of the change to the product. Not all upgrades require a full FDA review, but some upgrades do. Basically, if a change could affect safety or its intended use, a new 510(k)… Read more»

31470977 replied to the topic "The Nine Points of Design Control and How to Effictively Use and Understand Them." -

Mon, 09 Feb 2026 03:57:53 -0500

I agree with many of my classmates’ responses that a DHF should be treated like a living document. It is not something that should be done at the end of the project but something fabricated as the project is ongoing…. Read more»

31470977 replied to the topic "Remote or In-Person PM" -

Mon, 02 Feb 2026 04:15:30 -0500

I would prefer to work under a project manager that primarily communicates in person as I like that connection, and it makes me feel more involved in whatever project is being worked on. Having an online project manager is impersonable,… Read more»

31470977 replied to the topic "Product vs. Project Life Cycle Relationships" -

Mon, 02 Feb 2026 04:09:29 -0500

A product life cycle, from my understanding, describes the lifespan of a product from its creation until its retirement and is driven by business and operational needs while a project life cycle describes the temporary phases that a project goes… Read more»

31470977 replied to the topic "Sizes of Project Teams" -

Mon, 02 Feb 2026 04:03:29 -0500

I prefer to have a small team as the project feels a lot more personable to me. With a large team, while I am a lot more focused on a certain area, my heart is not in the project as… Read more»

31470977 replied to the topic "Maintaining the licenses for manufactures" -

Sun, 25 Jan 2026 03:10:14 -0500

After doing some additional research tied with this question, I believe that I can provide some additional information from jal58’s response. The FDA does not issue renewable licenses for medical devices. Instead, each manufacturer just has to ensure ongoing compliance…. Read more»

31470977 replied to the topic "The Cross Disciplinary Skills Needed in a Project Manager" -

Sun, 25 Jan 2026 02:44:39 -0500

I believe that a good project manager needs a lot of exposure to industry so they should have extensive work experience in research & development or systems engineering. However, I’m going to focus my response on college work. For an… Read more»

31470977 replied to the topic "How can a project manager excel in the Biomedical field?" -

Sun, 25 Jan 2026 02:00:49 -0500

In my opinion, a project manager in the biomedical field does not need to have a lot of technical expertise. Instead, they must have a good set of interpersonal skills and be able to read and extract information such as… Read more»