Activity | krp67 | Medical Device Courses

krp67 replied to the topic "Package Development Testing & Documentation" – 5 years, 10 months ago

I do not have experience with packaging but have heard from John Crombie the details associated with the packing. Early evaluation of product-packaging compatibility helps to detect design of manufacturing problems. In the worst case scenario that the packing does… Read more»
krp67 replied to the topic "''Quality Plan'' meaning ?" – 5 years, 10 months ago

In the purpose section of the QSPT (quality system plan template) the question of “Why?” must be answered. The purpose of this document is to ensure a quality system plan is in compliance with new and revised regulatory requirements. I… Read more»
krp67 replied to the topic "Stakeholders in Medical Device development" – 5 years, 10 months ago

I agree with as934 and additional to both voices, I want to examine the internal and external stakeholders briefly. We know employees can be considered stakeholders in a company. The first thought I had was laying off employees. Think of… Read more»
krp67 replied to the topic "New Medical Device Project" – 5 years, 10 months ago

This is a timely question to ask! I am in Capstone which is an academic setting however, the fundamentals are what is being taught due to time constraints. One fundamental concept is the customer needs which may be researched by… Read more»
krp67 replied to the topic "FDA Approves First Digital Pill in USA" – 5 years, 10 months ago

This medical device is both a device and drug, therefore it is considered a combination product as stated by regulation. The PMOA is too gather a signal of a patient who took their pill or not and monitors metabolic activity…. Read more»
krp67 replied to the topic "Challenges in the Global Regulatory Environment" – 5 years, 10 months ago

A few possible solutions if it were ideal situations. First, there should be a regulatory affairs individual from the company that is assisting or consulting with 30%- 50% of the project. This allows for technical input of what regulatory organization… Read more»
krp67 replied to the topic "Fitbit Medical Device?" – 5 years, 10 months ago

I say yes it should be regulated by FDA as a Class 1 device at maximum. The reason I state this because when I was taking a class in Medicine and Literature a common theme was commercialization. With commercialization in… Read more»
krp67 replied to the topic "Simulations" – 5 years, 10 months ago

Dr.Simon has mentioned how for Master students those of which have not taken design classes before unless you have been from NJIT as an undergrad, you know BME 383 (Mantilla) gets you prepared to do your own experiments with the… Read more»
krp67 posted a new topic "Medical Device Project" – 5 years, 10 months ago

If you haven’t noticed already the way Dr. Simon set-up the Final Project for the class was a Matrix Organizational Structure. Dr. Simon plays the role as Chief Executive Officer and over sees all that takes place. The project managers… Read more»
krp67 posted a new topic "PM in Pre-Clinical/Clinical Studies" – 5 years, 10 months ago

If anyone has taken Dr.Simon BME 682 class they know a little bit about Project management and in week 2 he discussed some aspects of PM. Where does PM fit into pre-clinical and/or clinical studies? Do we need planning (even… Read more»
krp67 posted a new topic "Skills Learned in this Class" – 5 years, 10 months ago

One important concept I learned in this class is to show appreciation for people and what they do for you. This is part of the 70% of social skills which are critical for having a great working environment. I realized… Read more»
krp67 posted a new topic "Communication Management" – 5 years, 10 months ago

Communication Management seems like a trivial knowledge area however, its seems as though it needs to be implemented in a PM. This topic of communication is critical. Lack of communication is why we have so many issues with marriages, friends,… Read more»
krp67 posted a new topic "PM: Timeline, Risk, Social Approaches" – 5 years, 10 months ago

From the simulation we just had we were asked various questions and had different responses to them in regards to the timeline for the overall project. Dr. Derek Malekai was the research team member- research scientist. He noticed that the… Read more»
krp67 posted a new topic "Project Integration Management" – 5 years, 10 months ago

Project Integration Managment (PIM) includes the processes and activities needed to identify, define, combine, unify and coordinate the various processes and PM activities within PM Process groups. In the PMBOK guide the definition of PIM is what I have provided… Read more»
krp67 posted a new topic "Program Management" – 5 years, 10 months ago

Dr. Simon has a diagram that has from left too right as follows: strategy -> tactics -> programs -> projects begin last. In the video, he spoke of this hierarchy of business logic. My dad works for ADP and he… Read more»
krp67 posted a new topic "Interpersonal Skills" – 5 years, 10 months ago

I do not have experience of working for industry, but from my academic career, I notice these skills were apparent in a few professors which have made them successful as a professor in my opinion. I believe these skills do… Read more»
krp67 replied to the topic Anti-kickback & Stark Cases in the forum Consultants and Legal Basics 6 years, 4 months ago

CMPL stands for Civil Monetary Penalties Law. In general CMPL are as result of mistakes made wither directly or indirectly against the law. As a consequence monetary compensation is required to be free of the act committed and/or partially makes one free of the debt they legally owe. Itis set by law makers how much a given act done wrongly costs.…[Read more]
krp67 replied to the topic NDA vs Patents in the forum Consultants and Legal Basics 6 years, 4 months ago

In the paper we were given by Dr. Simon it stated that Patents help to protect your innovation when you are harvesting the fruits of your invention. However, how do you help protect your invention during the critical phase? This is were a NDA comes in.

NDAs are quick to do and are legally binding. NDAs state that you can talk about trade secrets.…[Read more]
krp67 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics 6 years, 4 months ago

This is my second online class with Dr.Simon and I knew I would not be disappointed with the amount of information obtained form Dr. Simon. In particular to this course I learned the following:
– Medical device development has a plethora of jobs associated with it.
– I learned of job descriptions that I could research to understand if it was…[Read more]
krp67 replied to the topic Project Management Preferences in the forum Organizational Development in Device Companies 6 years, 4 months ago

To be a PM for an matrix Organization, as stated by @rv347 is difficult due to more responsibility given to you, more time needed to complete tasks and overall need to love working. So to be a PM of Matrix structure may have more turn over of employees due to the stress one acquires. To address this issue a PM if want they want to should work for…[Read more]
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