Medical Device Courses | jmeghai | Activity

jmeghai replied to the topic "Skills Learned in this Class" -

Sun, 02 May 2021 20:32:36 -0400

I have personally learnt a lot from this class. One of many is: how to work as a team. The simulation project allowed us to work in groups; where you determine how comfortable we would be working as a team…. Read more»

jmeghai replied to the topic "What is retention ?" -

Sun, 02 May 2021 18:38:13 -0400

In today’s candidate-driven job market, there is fierce competition to attract and retain employees. Regardless of any industry, employee retention should be top priority. A business can’t expand overnight, conjure up a new customer base out of thin air, or… Read more»

jmeghai replied to the topic "How was this class helpful" -

Wed, 28 Apr 2021 02:00:19 -0400

This class has taught me a whole lot and new found knowledge in project management. Felt like I took an entire program on project management. I have learnt time management and how to think fast to resolve problems with the… Read more»

jmeghai replied to the topic "Different PM techniques based on size" -

Thu, 22 Apr 2021 23:36:26 -0400

Your choice of methodology defines how you work and communicate. What methodology you choose will depend on your team, project-type, and project-scope. Every project is unique. Some projects are relatively straightforward and predictable. Others are highly complex and risky. Each… Read more»

jmeghai replied to the topic "What’s Your Motivator?" -

Wed, 21 Apr 2021 03:22:35 -0400

We all have what motivates us as humans and if we tie our goals to what actually motivates us, we excel and accomplish our goals. Also, motivation can be intrinsic (from within) or extrinsic (from outside yourself). Several factors can… Read more»

jmeghai replied to the topic "Discussion Topic: Outsource vs. Insource the clinical trial" -

Wed, 21 Apr 2021 01:54:45 -0400

Not all companies have the capacity or the resource to run a clinical trial in house. Also, depending on the size and the scope of the project will determine if the clinical trial should be outsourced or in source. The… Read more»

jmeghai replied to the topic "Six Sigma and Project Management" -

Fri, 16 Apr 2021 22:28:45 -0400

First, it’s important to see if Six Sigma methodology is a good fit for your project. What is the objective of this project? Is it to introduce new technology? Is it going to result in changing a job more than… Read more»

jmeghai replied to the topic "Discussion Topic: Risk Analysis methods" -

Wed, 14 Apr 2021 03:36:29 -0400

Risk identification can be a difficult task because it is often highly subjective, and no unerring procedures available that may be used to identify risk events and scenarios other than relaying heavily on the experience and insight of key project… Read more»

jmeghai replied to the topic "QA vs QC" -

Wed, 14 Apr 2021 01:03:36 -0400

Quality Assurance and Quality control are almost similar and sometimes mistaken to mean the same, but they are different. As part of the quality management, they are often used interchangeably. Both are related to each other, but they are different… Read more»

jmeghai replied to the topic "Discussion Topic: The proper time for Project Initiation" -

Mon, 05 Apr 2021 21:43:07 -0400

How much information is needed to begin a formal project can vary from company to company, even smaller companies do not all operate the same way. Also, it depends on what device or technology that is been developed or modified…. Read more»

jmeghai replied to the topic "Scope Creep" -

Mon, 05 Apr 2021 21:41:10 -0400

In every industry or company where a project is carried out, there is always a probability of a scope creep. This can occur when the scope of a project is not properly defined, documented, or controlled. It is generally considered… Read more»

jmeghai replied to the topic "Risk Management impact" -

Mon, 05 Apr 2021 21:39:19 -0400

Every project in any company or industry run into risk even the most meticulously planned project can run into risk. No matter how carefully laid your plan is, it can encounter unexpected issues you may not be prepared to handle…. Read more»

jmeghai replied to the topic "Monitoring & Controlling Techniques" -

Sun, 28 Mar 2021 14:42:14 -0400

Monitoring is about collecting data. Controlling is about analyzing that data and making decisions about corrective action. Taken as a whole, monitoring and controlling is about gathering intelligence and using it in an effective manner to make changes, as necessary…. Read more»

jmeghai replied to the topic "Closing Phase" -

Wed, 24 Mar 2021 23:23:12 -0400

In other to tell if a project is a success you need to check if the project met the goals and objectives of all deliverables, is the clients or sponsors of the project happy with the outcome, was the project… Read more»

jmeghai replied to the topic "Design Change Request" -

Wed, 24 Mar 2021 22:59:56 -0400

A change request is a formal request submitted by one of the project stakeholders to make a change to a project. Approval of a change request will result in the deviation from the original project plan that was created at… Read more»

jmeghai replied to the topic "Project Execution" -

Mon, 15 Mar 2021 00:21:45 -0400

Whatever project you are working on, in any industry, uncertainty is a common factor in every project which can include how much a project will cost, who will work on it, how long it will take, and whether or not… Read more»

jmeghai replied to the topic "Discussion Topic: The critical path" -

Fri, 12 Mar 2021 03:52:32 -0500

Basically, have not been opportune to work in a medical device company, however, every company have their project they work on, so also, do they have critical path that are somehow delayed or skipped during projects for various reasons which… Read more»

jmeghai replied to the topic "Executing Process" -

Wed, 10 Mar 2021 10:48:22 -0500

Every phase or process of developing and carrying out a project are all very important. If one is lacking the project falls apart or takes longer time and more money and resources to get the project executed. That been said,… Read more»

jmeghai replied to the topic "Meeting Deadlines with Research" -

Mon, 08 Mar 2021 03:20:54 -0500

This project simulation was quite tasking. We started off well by changing of the carrier of the bone growth factor and the syringe, however, along the line, we went to deep by proposing to carry out an animal test for… Read more»

jmeghai replied to the topic "Design validation" -

Mon, 08 Mar 2021 02:46:42 -0500

The Validate phase – is critical to the long-term success of the project. The transition from the Optimize phase to the Validate phase signals the end of the product creation process and the beginning of the effort to institutionalize the… Read more»

jmeghai replied to the topic "Design verification vs design validation" -

Mon, 08 Mar 2021 02:17:32 -0500

The difference between Design verification and Design validation can sometimes be confusing. But the differences between them are significant as confusing as they may be. Design verification determines if you’re building the product right. Are design outputs matching design inputs? Verification is… Read more»

jmeghai replied to the topic "Benefits of this course" -

Sat, 27 Feb 2021 12:18:05 -0500

There are so many benefits taking this course. This is the only Biomedical Engineering Program that goes in-depth into Project Management in Medical device. Like Dr. Simon said, NJIT is the only school that offers this course. Feels like an… Read more»

jmeghai replied to the topic "Estimating Project Timeline" -

Tue, 23 Feb 2021 16:21:59 -0500

Estimation in general is not an easy task when it comes to giving an estimate on budget, size of the project and timing. When estimating timeline for a project, you have to make sure that deadlines isn’t too tight thereby… Read more»

jmeghai replied to the topic "Most Important Phase" -

Tue, 23 Feb 2021 15:22:36 -0500

Like everyone has said, all phase of a project are very important and critical as well. Knowing that each of the phase in a project cycle do overlap each other. If the initiating phase isn’t properly done then the planning… Read more»

jmeghai replied to the topic "Discussion Topic: What are the PM elements in your company?" -

Mon, 22 Feb 2021 00:08:58 -0500

Currently working for a company that is bouncing back on their feet. Their current Enterprise Environmental Factors is not as strong as it use to be in terms of organizational culture. Basically, they are on the start of creating and collecting… Read more»

jmeghai replied to the topic "Communication and Responsiveness" -

Sun, 21 Feb 2021 03:20:01 -0500

In every organization, when handling a project, there is always that one person that is difficult to deal with; either they lack communication or are unresponsive and do not cooperate with the team members, which ends up having an impact… Read more»

jmeghai replied to the topic "Underestimating Task Duration" -

Wed, 17 Feb 2021 16:11:26 -0500

First, when beginning a project, during the initiating and planning stage, the timing and duration has to be factored into it. That being said, things do change or go wrong that were never planned for; contingency happens-resources, product getting approval,… Read more»

jmeghai replied to the topic "Discussion Topic: State of your Organization" -

Mon, 08 Feb 2021 14:48:57 -0500

The industry I work for it’s a cosmetic industry. It is more of a functional organization. All employees are grouped by specialty, skill or related roles. It is based on levels of hierarchy that include different departments, under the direction of… Read more»

jmeghai replied to the topic "General Wellness Product" -

Mon, 08 Feb 2021 14:14:33 -0500

Mental acuity refers to being mentally sharp. If you’re mentally sharp, you have an excellent memory, and you find it easy to complete different tasks. One’s mental acuity is affected by numerous elements like memory, focus, and the ability to… Read more»

jmeghai replied to the topic "Pros and Cons of the 3 Organizational Structures" -

Mon, 08 Feb 2021 13:22:13 -0500

There are a number ways you can structure your company management. Organizations must adapt to a suitable structure to achieve their business goals, whether that be a Functional, Projectized, Matrix, or other type of structure. A functional organizational structure is the… Read more»

jmeghai replied to the topic "Safety Recalls" -

Sun, 07 Feb 2021 11:42:32 -0500

Recalls occur when a medical device or product is defective, when it could be a risk to health, or when it is both defective and a risk to health. More than 60 percent of FDA recalls are due to labeling… Read more»

jmeghai replied to the topic "Ideal project team" -

Fri, 05 Feb 2021 04:21:26 -0500

Choosing a project team requires diligence on the project manager in other to choose those who will better execute the project to the maximum required result or outcome. First, you have to consider what device or product is involved. Then… Read more»

jmeghai replied to the topic "Determining project priority" -

Fri, 05 Feb 2021 01:15:55 -0500

I think low priority project should be cancelled to give or accommodate more resources to the high priority project. Before decision on this are made, during the initial phase, the Project objectives should be carefully analyze to see if the… Read more»

jmeghai replied to the topic "Discussion Topic: Projects of all types" -

Thu, 28 Jan 2021 11:42:53 -0500

Project Management is the application of knowledge, skills, tools, and techniques to project activities to meet the project requirements. Project management brings a unique focus shaped by the goals, resources and schedule of each project. Every project manager has the… Read more»

jmeghai replied to the topic "Project Manager Skills" -

Thu, 28 Jan 2021 10:46:07 -0500

A project manager needs to have special abilities for successfully executing projects from initiation till closure. And there are lots of essential skills that a project manager should posses which can be grouped into the interpersonal skills and technical skills…. Read more»

jmeghai replied to the topic "''Quality Plan'' meaning ?" -

Thu, 28 Jan 2021 10:15:52 -0500

Quality planning refers specifically to the actions of the project management team and or the project management team leader to engage in the action of establishing and conducting a process for the purposes of identifying and determining exactly which standards… Read more»

jmeghai liked forum post "Best timing for validation and verification" -

Tue, 26 Jan 2021 01:02:55 -0500

jmeghai replied to the topic "Best timing for validation and verification" -

Sun, 24 Jan 2021 04:11:17 -0500

Verification and validation is the process of investigating that a medical device satisfies and meets specifications and standards and it fulfills the required purpose. That being said, verification takes place while the product is still under development. At every stage… Read more»

jmeghai replied to the topic "Interpersonal skills vs technical knowledge" -

Sun, 24 Jan 2021 03:14:26 -0500

In today’s world, interpersonal skills are sought after despite the fact that technical skills are very important, but then it varies with profession. While certain technical skills are necessary for any position, employers look for people with interpersonal skills and… Read more»

jmeghai replied to the topic "Initiating a Project Idea" -

Sat, 23 Jan 2021 13:56:32 -0500

Beginning or starting anything; be it project, chores, work etc. is always a struggle but when you pass the huddle of starting, then you have a smooth sailing and becomes much easier to go through the process. Initiating a project… Read more»

jmeghai replied to the topic "NDA vs Patents" -

Sun, 29 Nov 2020 02:04:05 -0500

For one I would say both a patent and an NDA are needed to sign and secure your ideas and invention in a contract. NDA is simply a contract between two people. While Patent is a federal document proving ownership of… Read more»

jmeghai replied to the topic "Non Compete Agreement" -

Sat, 28 Nov 2020 14:20:47 -0500

I haven’t been in any situation where I have to sign a Non Compete Agreement but from what I have read and what people went through, it something you need to be well educated on and get a legal person… Read more»

jmeghai replied to the topic "Discussion Topic: Course conclusion and impressions" -

Tue, 24 Nov 2020 12:21:30 -0500

This course in generally as been an eye opener to the Medical Device world. This explain in details all you need to know about the industry and how each roles overlap each other. I am excited I took this course,… Read more»

jmeghai replied to the topic "Medical Device Project" -

Mon, 23 Nov 2020 04:51:49 -0500

As we begin our final project, it gradually refines you and shows you how the real industry is. This is more like a preparation of what to expect out there. And the organization type Dr. Simon went with seems more… Read more»

jmeghai replied to the topic "Organization types of medical devices?" -

Sun, 22 Nov 2020 13:33:05 -0500

Every organization is different and no organizational structure is perfect, but one of the above types of organizational structure may be best for a medical device company depend on the size of the company and what growth the foresee to… Read more»

jmeghai replied to the topic "Discussion Topic: Your organizational type" -

Sun, 22 Nov 2020 00:12:24 -0500

Though not current working in a medical device company, but I would classify my organization as more of a functional type organization where by each department has a functional head of that department. And as stated in the course material… Read more»

jmeghai replied to the topic "Discussion Topic: Risk Management, Risk Analysis" -

Sun, 15 Nov 2020 20:50:04 -0500

According to ISO 14971, the principles for Risk Management requires that risk be reduced as low as reasonably-practicable. The primary objective of the ISO 14971 is to provide protection primarily to patients and also to the operator, other persons, equipment… Read more»

jmeghai replied to the topic "What is Risk-benefit analysis ?" -

Fri, 13 Nov 2020 11:56:30 -0500

Risk-Benefit analysis is one of the central features of Risk Management. It is one of the most important principle in the ISO 14971. In September 11, 2019, the FDA release some factors to consider when making Risk-Benefit determination in Medical… Read more»

jmeghai replied to the topic "Risk management methods" -

Thu, 12 Nov 2020 02:40:57 -0500

There are lots of tools and methods used in managing risk. That been said we do not want to confuse “ways on how to deal with risks” with the actual tools or methods needed to manage or mitigate risk. The… Read more»

jmeghai replied to the topic "Design Controls in the other countries" -

Mon, 09 Nov 2020 01:07:51 -0500

Design control been included into the ISO regulation was a big plus. This has enabled medical device companies in other countries to have a set standard to work with. Thus, Design controls are mandated so that medical device companies can… Read more»