https://medicaldevicecourses.com/members/rajamharrison/activity/ Activity feed for rajamharrison. Fri, 24 Apr 2026 17:08:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 f5e9f0293cf444534f7b7e04a4d3ca8d https://medicaldevicecourses.com/activity/p/23743/ Sat, 16 Oct 2021 15:38:11 -0400 Posted by: @kbs27 Hi all, In the video lecture Dr.Simon mentioned about two terms of contract,Written & Verbal agreement. He said that verbal contract can be legal but what if the due to dispute or other reason the verbal agreement…   Read more»

]]> 03ca40a81a787fe767f0bac0bd5657e2 https://medicaldevicecourses.com/activity/p/23742/ Sat, 16 Oct 2021 15:23:45 -0400 Posted by: @cef3 So there may be more than just the 3 main organization types that Dr. Simon presented in the lecture: http://blog.hubspot.com/marketing/team-structure-diagrams. Say you were to start up a medical device company that will function worldwide. What type of…   Read more»

]]> 685a258918a5bc67f559b0d39344c5dd https://medicaldevicecourses.com/activity/p/23741/ Sat, 16 Oct 2021 15:07:28 -0400 Posted by: @zcornelius21 There are multiple types of organizations within project management that have there own way of playing a majored role in how projects are carried out. How do organizational structures affect projects and project management? Organizational structures affect…   Read more»

]]> 0401c1d8a9d73d260f0af7d7f62cea03 https://medicaldevicecourses.com/activity/p/23659/ Sun, 10 Oct 2021 01:10:29 -0400 @traceymraw I agree with you Tracey. You make some really interesting points in your reply.  Some risk are necessary because they are unavoidable for the effectiveness of the product.  The examples you used are great as well.  Like the bone…   Read more»

]]> a7871ad344120cd1ec936eb70ca1fcfc https://medicaldevicecourses.com/activity/p/23658/ Sun, 10 Oct 2021 01:10:23 -0400 @traceymraw I agree with you Tracey. You make some really interesting points in your reply.  Some risk are necessary because they are unavoidable for the effectiveness of the product.  The examples you used are great as well.  Like the bone…   Read more»

]]> 6d19dbd5b50b40244c2622ba53f2c9a7 https://medicaldevicecourses.com/activity/p/23657/ Sun, 10 Oct 2021 01:03:24 -0400 Do you believe risk management is an important part of the planning phase?  Is it necessary or it is just a waste of money and time? Why?

]]> dea3f82828c31f0c1c75e7f1402561b6 https://medicaldevicecourses.com/activity/p/23656/ Sun, 10 Oct 2021 01:01:54 -0400 Implementing risk management is a benefit because it allows the medical device company/ manufacture to be ahead of the game. It allows them to release the warnings and side effects before anyone has a chance to experience them when the…   Read more»

]]> 0c5e349f1eacbfea58dda3695cc2d877 https://medicaldevicecourses.com/activity/p/23551/ Sat, 02 Oct 2021 17:50:41 -0400 I believe that minutes of a meeting are important because it is a very detailed and organized document that entails everything discussed.  The meeting could mention how the company is implementing a new procedure soon and that everyone needs a…   Read more»

]]> bf3b2da16dbdeca093d79ae4dfa07f92 https://medicaldevicecourses.com/activity/p/23550/ Sat, 02 Oct 2021 17:44:03 -0400 Posted by: @fgk4 As we all have learned this week, a validation may not be required if:- There were no changes required to the product after verification.- A clinical trial is not required- Product changes did not affect the user…   Read more»

]]> 98846208c910119afd322b9d4fab5bcb https://medicaldevicecourses.com/activity/p/23549/ Sat, 02 Oct 2021 17:38:11 -0400 Posted by: @hg93 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and…   Read more»

]]> 56db3a08e568997331c000dbdc4dd593 https://medicaldevicecourses.com/activity/p/23461/ Sat, 25 Sep 2021 15:47:47 -0400 I agree with @samscott.  Being that all the research is being done in real time, we can not sit and compare multiple data points to test your theory @mejefferson.  I would like to think that certain vaccines work for certain…   Read more»

]]> 1ea31bfd32aeb42f31e6edf68d6f7b42 https://medicaldevicecourses.com/activity/p/23460/ Sat, 25 Sep 2021 15:42:55 -0400 Posted by: @smitshah I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not know about the drug and…   Read more»

]]> 507b72d8d031c8e6786dba01ae884898 https://medicaldevicecourses.com/activity/p/23459/ Sat, 25 Sep 2021 15:34:51 -0400 Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

]]> 632f2afa79e68d77841f9156bced2f9c https://medicaldevicecourses.com/activity/p/23450/ Sat, 25 Sep 2021 01:51:28 -0400 Posted by: @srg36 I have a question about family businesses. Say for example someone started a sole proprietorship, and down the road the business grows and is successful, and that person wants to pass the business on to his 2…   Read more»

]]> 25dfd8bf04cc978a3b2ccb11cae5274d https://medicaldevicecourses.com/activity/p/23449/ Sat, 25 Sep 2021 01:47:03 -0400 Posted by: @tulikadasp A DBA( doing business as) allows a company to transact business using a different name. It generally takes place at the county level, but some states have state-level DBA filings. For sole partnership or partnership, unless a…   Read more»

]]> d1616051c309f50a4b596afeb147c88b https://medicaldevicecourses.com/activity/p/23447/ Sat, 25 Sep 2021 01:38:15 -0400 Posted by: @sahitya-sadineni After watching the videos from this week’s lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position based on the type of company it is? For me…   Read more»

]]> 3bbeac53388cdd13d3695cc8b2fa2ac9 https://medicaldevicecourses.com/activity/p/23289/ Sun, 12 Sep 2021 04:12:40 -0400 Posted by: @sahitya-sadineni Although science has been around for a while, technology is something that has been evolving in the past 20 years. Pre-clinical is very important to every and any kind of medical research. But what is also important…   Read more»

]]> 914aab497622bd3cab953ba4947f7af6 https://medicaldevicecourses.com/activity/p/23288/ Sun, 12 Sep 2021 04:06:26 -0400 Posted by: @yroberts Preclinical research trials are know to be performed on a single lab creature such as rodent, pig, fruit fly, or monkey. Most recent research appears that having an animal model and conditional differences in the studies can…   Read more»

]]> 23d0f6630a50d48f99a656abb824685a https://medicaldevicecourses.com/activity/p/23287/ Sun, 12 Sep 2021 04:00:26 -0400 Posted by: @arianaburch If you had to select right now if you would work Academia or Industry, which would you decide? Their approaches to research are different and yet similar at the same time. Did their approaches to research aid…   Read more»

]]> dddcfd610f35c412e37ae2adb3339519 https://medicaldevicecourses.com/activity/p/23286/ Sun, 12 Sep 2021 03:48:44 -0400 Posted by: @mejefferson The medical device development process requires specific stages to be followed to ensure design control so that the product is both effective and safe for use. As a result, this covers the entire product development cycle, from…   Read more»

]]> b8cd45c538ba33dbb9bc701b0b05f6a4 https://medicaldevicecourses.com/activity/p/23285/ Sun, 12 Sep 2021 03:43:49 -0400 Posted by: @266 Academically speaking, would you rather be overqualified for your job or meet the bare minimum qualifications? What are some short term and long term pros/cons for either situation? Academically speaking, I would rather meet the bare minimum…   Read more»

]]> 5eb0db3b2bcec5bbe6359708b1e666d5 https://medicaldevicecourses.com/activity/p/23284/ Sun, 12 Sep 2021 03:32:23 -0400 Posted by: @orleron We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all…   Read more»

]]> 36587f48d2f0b472c7e00d69bd43afcb https://medicaldevicecourses.com/activity/p/23283/ Sun, 12 Sep 2021 03:24:18 -0400 Posted by: @bb254 Based on your work experience in any company, what were some issues you found with the quality department and how would you fix them? For example:I work in the manufacturing department of a medical device company but…   Read more»

]]> f5820adf5f140431749c88311078cf01 https://medicaldevicecourses.com/activity/p/23282/ Sun, 12 Sep 2021 03:13:43 -0400 Posted by: @hruship101 Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product launch or to prevent the…   Read more»

]]> 7cfb5861d8254946c4289c683c300106 https://medicaldevicecourses.com/activity/p/23281/ Sun, 12 Sep 2021 03:05:37 -0400 The head of a quality team is a quality manager.  This role consist of a person who makes all of the quality decisions.  In my field of work, industrial, those decisions entail releasing a product if it has an out…   Read more»

]]> b8186206b7552b3205a7c04e8b5a967f https://medicaldevicecourses.com/activity/p/23052/ Tue, 24 Aug 2021 17:29:33 -0400 In case of emergency, physicians can use medical devices if they haven’t been approved by the FDA yet if it will help cure their patient.  The physicians is given a go to use an unapproved device if: 1. The patient…   Read more»

]]> 94a6168504c3dc2670c460add4c3fc90 https://medicaldevicecourses.com/activity/p/23051/ Tue, 24 Aug 2021 17:29:32 -0400 Posted by: @mejefferson The Global Harmonization Task Force (GHTF) which is currently the International Medical Device Regulators Forum (IMDRF), has a goal of bringing together medical device regulatory systems around the world by enhancing patient safety and increasing access to…   Read more»

]]> c41b98c94afb725a9592938cd54d6433 https://medicaldevicecourses.com/activity/p/23050/ Tue, 24 Aug 2021 17:29:32 -0400 The classes are ranked according to their risk, or their safety and efficacy as mentioned above.  Class 2 medical devices are those that have moderate to high risk to patients. The only thing I really found on Class 2 medical…   Read more»

]]> 7220dfc310d6c586bd245ec336e9fe89 https://medicaldevicecourses.com/activity/p/23040/ Tue, 24 Aug 2021 17:29:14 -0400 Good question Meagan.  I feel like these upper management positions should be filled with staff members who understands the business and works their way up.  I feel this way because, being a staff member myself, I feel like I can…   Read more»

]]> 93198f54163259705cccb5ca981e2f50 https://medicaldevicecourses.com/activity/p/23039/ Tue, 24 Aug 2021 17:29:13 -0400 Posted by: @rowel2202 When have your organizational skills helped keep a project on track? Does the organizational structure your work in determine how you prioritize the workload? or do you have a set system regardless of leadership ? My organizational…   Read more»

]]> 964cb8fd9e84bae32fde6f82b3967bab https://medicaldevicecourses.com/activity/p/23038/ Tue, 24 Aug 2021 17:29:12 -0400 Posted by: @zcornelius21 What are the advantages of grouping projects under a program? The advantages of grouping project under a program is that you have the ability to initiate, define, accelerate or terminate projects in a program.  Another benefit is…   Read more»

]]> 83a3eff1076c30eb1d15b4adc9fcc70c https://medicaldevicecourses.com/activity/p/23032/ Tue, 24 Aug 2021 17:28:07 -0400 Posted by: @devarshi-joshi According to me the most important 5 success factors are:1)Agreeing on the project goals2)Effective Communication3)Develop clearly defined plans with assigned responsibilities.4)Managing project scope effectively.5)Making sure of management support. So how are these factors individually important for a…   Read more»

]]> c220b9aadf1763af8ca9b7686e63c2cf https://medicaldevicecourses.com/activity/p/23031/ Tue, 24 Aug 2021 17:28:05 -0400 f9a65166f5ac3716280a334336ef56bc https://medicaldevicecourses.com/activity/p/23030/ Tue, 24 Aug 2021 17:28:04 -0400 As a lab technician, a huge part of our job is logging work because when we need it later on down the line we’ll have it stored so it can be easily found. At my former job, it was more…   Read more»

]]> 56725d63782e760d93c88d80dce17023 https://medicaldevicecourses.com/activity/p/23025/ Tue, 24 Aug 2021 17:26:59 -0400 Posted by: @krp76 During the planning phase of a project estimations play a critical role. For medical device projects the cost estimation is not always straightforward as discussed in the lectures. Another estimation that can be misleading is the task…   Read more»

]]> 1b87c8757eb6ef8d62b723471ecb04cb https://medicaldevicecourses.com/activity/p/23024/ Tue, 24 Aug 2021 17:26:59 -0400 In this course I learned that there is a lot more to planning a project than what I thought.  I initially thought planning a project consisted of figuring out what the focus for the project would be and everything else…   Read more»

]]> 910709b6a9ca6385e0ccf5bd2091b488 https://medicaldevicecourses.com/activity/p/23023/ Tue, 24 Aug 2021 17:26:58 -0400 Posted by: @sp2387 Planning phase is the most important and basic phase according to me. If you are planning it should be practical because after all it has to be executed. Each and every step of any project should be…   Read more»

]]> 6cf49b443fb922eddf045e1493dbaccb https://medicaldevicecourses.com/activity/p/23018/ Tue, 24 Aug 2021 17:26:21 -0400 This would honestly be an easy fix as long as the team is fully staffed and proper protocols are followed.  If I was the PM, I would firstly make sure that my team is fully staffed and have multiple people…   Read more»

]]> 101774d44e7e921b345b08397a35b2c9 https://medicaldevicecourses.com/activity/p/23017/ Tue, 24 Aug 2021 17:26:20 -0400 Posted by: @amin-sadig We learned a lot about scheduling and task delegation this week and one major question arose. If the PM changes at different phases of a project (beginning, mid, near conclusion), and the an error in the scope…   Read more»

]]> 068197b659cbb9ec5fba811379ded527 https://medicaldevicecourses.com/activity/p/23016/ Tue, 24 Aug 2021 17:26:19 -0400 Posted by: @amin-sadig From as early as the mini sim we were told to consider outside factors such as vacation times for inspectors when planning a schedule so we don’t get delayed unnecessarily. Because the job of a PA is…   Read more»

]]> 95670215cf4da5cd9a75bcc7a9cad87f https://medicaldevicecourses.com/activity/p/23010/ Tue, 24 Aug 2021 17:25:35 -0400 Great question Meagan. I would suggest that the stakeholders just continue to follow the financial statistics of the project because thats usually all they are well versed in when it comes to different projects.  If they start getting involved in…   Read more»

]]> 2a0542e6e1a51ff69d8ca22fc030bb5f https://medicaldevicecourses.com/activity/p/23009/ Tue, 24 Aug 2021 17:25:35 -0400 Personally, I think the planning phase is the most important phase of a project.  While I agree with Meagan that all phases and processes are equally important, I also believe that without a solid planning phase, where each step has…   Read more»

]]> 4d3c7afe7c4432a43ad4d376f8095702 https://medicaldevicecourses.com/activity/p/23008/ Tue, 24 Aug 2021 17:25:34 -0400 5fb936d2d68aec8534850a79b84730f9 https://medicaldevicecourses.com/activity/p/23003/ Tue, 24 Aug 2021 17:25:30 -0400 Posted by: @mejefferson From all of the knowledge we have gained throughout PMP, from the basics, to the project life cycle and organizations, to breaking down each process, down to managing a project, do you think you have the potential…   Read more»

]]> 3220b05c6f644b14a5870f5985b5ba1d https://medicaldevicecourses.com/activity/p/23002/ Tue, 24 Aug 2021 17:25:30 -0400 Posted by: @nakimw Say that someone on your project team changes positions to a different job so that you no longer have said person to perform a critical task for the project. His or her assigned task not being done…   Read more»

]]> 35611af423668a782b2721542f4f9d94 https://medicaldevicecourses.com/activity/p/23001/ Tue, 24 Aug 2021 17:25:29 -0400 Posted by: @aasutosh-purohit In the lecture we studied about Quality Assurance and Quality control. How these both are different from each other? Quality Assurance is the maintenance of a desired level of quality in a service or product, especially by…   Read more»

]]> 7ff947473f44c3b16681785e2d6f5bcd https://medicaldevicecourses.com/activity/p/22876/ Mon, 05 Jul 2021 15:15:17 -0400 0