https://medicaldevicecourses.com/members/ssbufford/activity/ Activity feed for ssbufford. Fri, 24 Apr 2026 19:23:05 -0400 https://buddypress.org/?v= en-US 30 hourly 2 71ef2312c165a4e3a67ef51e31d865f1 https://medicaldevicecourses.com/activity/p/22733/ Thu, 24 Jun 2021 07:36:58 -0400 My personal reflection: I understand that this is an MSBT, but I was not exactly sure what to truly expect. The course was very informative for me. I learned a lot of fundamentals that I was not aware of, I…   Read more»

]]> f53767cf540969caf08069a61011dc36 https://medicaldevicecourses.com/activity/p/22732/ Thu, 24 Jun 2021 07:29:33 -0400 The type of organization that I work in Matrix Organization (for the Department of Defense for the Army Medical Command).  I was working in data analysis for over 10 years in Health Administration in different sectors moving around for the…   Read more»

]]> e40dd72005dc96d8d217a9b3643c2d61 https://medicaldevicecourses.com/activity/p/22731/ Thu, 24 Jun 2021 07:26:01 -0400 Verbal agreements are oral and are not enforceable by the law nor is it legally binding. Therefore it can be easily dismissed for a number of reasons.  A written agreement is documented and therefore is evidence-based. It can be followed…   Read more»

]]> f46e7776092e4c301cb9675791ffc20b https://medicaldevicecourses.com/activity/p/22691/ Thu, 17 Jun 2021 04:07:51 -0400 Risk benefit analysis is basically a comparison between the risks and the benefits of the situation.  It is used to figure out if the course of action to be implemented is worth the risk or if the risk is too…   Read more»

]]> 7d31caeb920fc6d009ac020dc14c5c23 https://medicaldevicecourses.com/activity/p/22690/ Thu, 17 Jun 2021 03:56:38 -0400 A risk management file is a living document that notates risk management activities, documentation, and records for the project. This living document provides evidence of the risk management plan, risk analysis, and risk evaluation. All three areas are important to…   Read more»

]]> 7eb6832eabf2d35cfc258f9179776589 https://medicaldevicecourses.com/activity/p/22689/ Thu, 17 Jun 2021 03:47:23 -0400 Post market surveillance is the requirement that medical devices have to continue to be monitored after they have been cleared for sale and placed on the consumer market for purchase.  It is a very important factor because it demonstrates the…   Read more»

]]> b994fb71d7629ba45ab07d79b28fbae2 https://medicaldevicecourses.com/activity/p/22657/ Thu, 10 Jun 2021 02:49:46 -0400 DHF can be audit ready if the organization is ensure a set of checks points are conducted prior.  In my organization a living document that we have in my department is for provider rounds documentation for inpatient consults or rounds…   Read more»

]]> 1652808d198a860b0113bee6275500ec https://medicaldevicecourses.com/activity/p/22656/ Thu, 10 Jun 2021 01:52:42 -0400 Why do you think Verification is important ? and Your ideas to improve Verification process in a design control ? Verification is an important process in the development of medical devices because it is the “check phase” as Dr. Simon…   Read more»

]]> 94f413e3dbdf93608a935cedeaab3d43 https://medicaldevicecourses.com/activity/p/22655/ Thu, 10 Jun 2021 01:24:28 -0400 I consider the customer’s input the most important part of the design control.  Why? I believe all steps in the design control are some what important but I believe that the customer input is the most important because a product…   Read more»

]]> 81184a4cf076800bfa9239a104a9bed3 https://medicaldevicecourses.com/activity/p/22594/ Thu, 03 Jun 2021 04:41:59 -0400 Yes, someone very close to me suffers adverse events (effects) as a result of medication that they take for TBI. Traumatic Brain Injury (TBI) alters the brains ability to effectively communicate at all times.  There are a few treatments available…   Read more»

]]> f937142f593944245ffebe36dd8845d1 https://medicaldevicecourses.com/activity/p/22593/ Thu, 03 Jun 2021 04:34:09 -0400  This topic is near and dear to my heart, Ms. Lacks and her family endeavored and are still processing through the legalities of her cells being taken without her consent while she was alive. The fact that her cells are…   Read more»

]]> 2ca0528dbda6ba923ab1b1929c88c542 https://medicaldevicecourses.com/activity/p/22591/ Wed, 02 Jun 2021 19:26:34 -0400 In regards to the CRA, monitor, and statistician, from my previous background, it is a plus but not required that individuals what is most important is that they have educational background and knowledge in sciences and some health care administration/…   Read more»

]]> f059634e9c664280dc574c1be9ac9b96 https://medicaldevicecourses.com/activity/p/22554/ Thu, 27 May 2021 05:44:56 -0400 Piercing the corporate veil is a new concept to me so when I saw this post I was interested and wanted to do a little research. When I think of a veil, I immediately think of the bible and neuroscience. …   Read more»

]]> 671a1a33748d95a1abdb2aa9e22c1e3c https://medicaldevicecourses.com/activity/p/22553/ Thu, 27 May 2021 05:44:07 -0400 I do not have personal experience with owning a family business and how to delegate and pass down the duties and responsibilities of a business, but I would like to weigh in with assumptions.  I would assume that the parents…   Read more»

]]> 07bc4f254f5b783624e8ca0fab37a99a https://medicaldevicecourses.com/activity/p/22552/ Thu, 27 May 2021 05:43:18 -0400 This is a great question, in the past prior to graduate school this was something that I have gave minimum consideration, literally I would base my opinion on if the name or what I “thought” the company stood for, was…   Read more»

]]> 3395ef400f74af4473962c9aa734df8b https://medicaldevicecourses.com/activity/p/22501/ Thu, 20 May 2021 02:55:34 -0400 I have several examples of Quality department issues with work experience over the years. To be specific, I will talk about our quality department where I currently work. Unfortunately, depending on the organization, people are able to get away with…   Read more»

]]> 2278a5d28a7e46f76a69b5213f91a193 https://medicaldevicecourses.com/activity/p/22500/ Wed, 19 May 2021 21:36:06 -0400 If I am QA auditor, there are two things that I am going to focus on: identifying the deficiencies of the regulatory framework of the project and to identify employees who are non-compliant. It should be understood that FDA standards…   Read more»

]]> 5e8e67eee44e17519d10a264696ed9d8 https://medicaldevicecourses.com/activity/p/22499/ Wed, 19 May 2021 21:01:24 -0400 Working in a military hospital that services civilians in the city in which we are located I have seen poor quality of service due to incorrectly written consults for additional services and treatments for patients.  We have a quality assurance…   Read more»

]]> 0dbd34371ee1a7a17bcb25917071e8d9 https://medicaldevicecourses.com/activity/p/22458/ Tue, 11 May 2021 22:12:48 -0400 As research scientist I venture to say I want both, I want my work to be beneficial for today’s access and I want my work to inspire and lead to discoveries or pathways to new aspirations at the same time….   Read more»

]]> 0e1ef503d90a3559d0d177bc6133e33e https://medicaldevicecourses.com/activity/p/22457/ Tue, 11 May 2021 22:00:23 -0400 Yes, all living things have rights, so do animals; there is never a just cause to be cruel. In the same aspect, I believe animal testing is a crucial step that is needed to protect humans. As we discuss making…   Read more»

]]> b6a98002155d7d93d83cc02fabb9b075 https://medicaldevicecourses.com/activity/p/22456/ Tue, 11 May 2021 21:18:57 -0400 PETA as a organization I believe has the correct motives however, there are quite a few principles that they stand by that I do not agree with. With that being said, my career goal is and view point is that…   Read more»

]]> 04fdbfaae9c5af812e15089ca8a1c973 https://medicaldevicecourses.com/activity/p/22449/ Mon, 10 May 2021 05:20:59 -0400 @gfashaw Thank you for preparing our children for the future. I agree with your viewpoint and at this time it seems that where we were once very divided as a country, there is seeming to be some meeting in the…   Read more»

]]> d427ed24999b666bfd2da5115fcdee3c https://medicaldevicecourses.com/activity/p/22448/ Mon, 10 May 2021 05:17:52 -0400 @armoneee 
great point! Thank you for sharing your thoughts. Have a great week. 

]]> 5fc96524f20987ef5cf944e5f0d096de https://medicaldevicecourses.com/activity/p/22415/ Thu, 06 May 2021 06:13:50 -0400 Great question and I too wonder something similar. Nowadays the recently educated or currently in college individuals, are stuck in a tough space.  American society wants us to have years of education and years of experience. However, the problem with…   Read more»

]]> 52618bd0f1fee20be931969a4447bb8f https://medicaldevicecourses.com/activity/p/22414/ Thu, 06 May 2021 06:05:51 -0400 The medical device industry most certainly felt the shift from the covid 19 pandemic.  Medical devices are an industry that needs resources to thrive. It simply cannot be a successful industry without the materials needed to be innovative. If you…   Read more»

]]> c059f0d9fdd9a583e80615a491122607 https://medicaldevicecourses.com/activity/p/22413/ Thu, 06 May 2021 05:57:16 -0400 Working in a hospital I see how covid has changed the way in which cotton swabs and oxygen masks are utilized; just medical devices, in general, are used in the hospital. At the hospital in which I work the primary…   Read more»

]]> fe1458fecb9a0db0fcf32b34b3bb1e76 https://medicaldevicecourses.com/activity/p/22227/ Wed, 21 Apr 2021 04:29:44 -0400 If my team was to have a team member switch to a new role during the middle of a project first thing I would do as a team member myself is evaluate how this member changing positions will affect my…   Read more»

]]> f7a4d1e9275e88ca23a5babe1b2c9fd5 https://medicaldevicecourses.com/activity/p/22226/ Wed, 21 Apr 2021 04:20:13 -0400 In my time working at the current organization that I am in, the HRM standards have not been truly met.  Human Resources Management is critical in hiring the right person for the department. Job applications and questions are supposed to…   Read more»

]]> e0d6df486bca62293b542dd59c3066f1 https://medicaldevicecourses.com/activity/p/22225/ Wed, 21 Apr 2021 04:08:37 -0400 I also agree that communication is at times a lost cause but most importantly not always conveyed correctly. It is critical for the success of a project that various groups need to know what other various project groups are doing…   Read more»

]]> 216432f3a916eb0b9b48aa3b9e558387 https://medicaldevicecourses.com/activity/p/22121/ Thu, 15 Apr 2021 06:41:17 -0400 As the PA the first thing that needs to be addressed is the PA’s obligation to the team.  The PA has to have the soft skills in which to be effective in communication to lead a team.  If I was…   Read more»

]]> 073f0d3c59e4942aea532da6a42f7907 https://medicaldevicecourses.com/activity/p/22120/ Thu, 15 Apr 2021 06:19:42 -0400 I reviewed Dr. Simon’s website, Spiral Medical Development (https://www.spiralmeddev.com/)and it is a very nice consulting website. I am not familiar with MD consulting but it is very informative and pleasant to the eye, as well as very well organized. This…   Read more»

]]> a6c64f2d870c5354e699496ede4b1f2c https://medicaldevicecourses.com/activity/p/22119/ Thu, 15 Apr 2021 05:35:32 -0400 I currently work in a field where we constantly have multiple projects going on at once, so we multitask constantly. Prior to Dr. Simon’s course, I have completed Lean Sigma Six and have a basic understanding as well as I…   Read more»

]]> 19958295e8c320c761222f68529f7c53 https://medicaldevicecourses.com/activity/p/22023/ Thu, 08 Apr 2021 06:51:03 -0400 Nice article, Is innovation bad for business from a project management perspective? Yes, in my opinion, specifically discussing the implementation stage of gene therapies that cure patients of ailments is not a very financially secure idea from a project management…   Read more»

]]> ce7a93a937993af3bc9261b0f17c651e https://medicaldevicecourses.com/activity/p/22022/ Thu, 08 Apr 2021 06:33:32 -0400 Scope creep is a real “thing” in the federal government, I guess it depends heavily upon the agency in which you work for.  Scope creep in my opinion is when you are given additional tasks so much so where it…   Read more»

]]> e088d43376f3784240e8f202023c5d65 https://medicaldevicecourses.com/activity/p/22021/ Thu, 08 Apr 2021 05:51:31 -0400 All five factors mentioned are important in the success of the project. Dr. Simon has said repeatedly, “If you fail to plan, you plan to fail”, and as we continue to progress through this PM course I can see the…   Read more»

]]> 7c3b36c0f709dfe4b1f6efc47e6913ff https://medicaldevicecourses.com/activity/p/21952/ Thu, 01 Apr 2021 07:27:41 -0400 Monitoring and controlling techniques provide the business with a tangible means of checks and balances as well as keeps the team members honest. Correspondence control is a vital element in the monitor and controlling of projects in my opinion because…   Read more»

]]> 893276369d67111f6a20c9897bac4e13 https://medicaldevicecourses.com/activity/p/21951/ Thu, 01 Apr 2021 07:12:55 -0400 Keeping a work log is a great way to be prepared to validate your logged time at your job for the week. I keep a work log and have been for about 10 years, I’ve been a Department of Defense…   Read more»

]]> 3b373893d0eec6394e1036771ecf5638 https://medicaldevicecourses.com/activity/p/21950/ Thu, 01 Apr 2021 06:42:21 -0400 A calm and productive discussion is always the best and most professional route in which to come to a mutual understanding in regards to work.  When that is not the case, sometimes as a leader or even a non-designated leader…   Read more»

]]> 6bf042cdf469eda541179903487833c8 https://medicaldevicecourses.com/activity/p/21860/ Wed, 24 Mar 2021 23:49:03 -0400 There are many reasons as to why a project can fail to meet the customer’s needs, after reading an article on the pmi.org website there are several factors that are important to understand. The main subject I want to address…   Read more»

]]> 024f659eb9f1a5840ac09be6f7880c7e https://medicaldevicecourses.com/activity/p/21854/ Wed, 24 Mar 2021 07:51:01 -0400 That is great news! Well, I am actually a Biotechnology Major and my goal is to actually become a Research Scientist in the field of Biomedical Science. I am taking Dr. Simon’s course out of necessity. I really was not…   Read more»

]]> 2483c6e3b6530b5a2d1ffd2215c0073d https://medicaldevicecourses.com/activity/p/21853/ Wed, 24 Mar 2021 07:38:38 -0400 As a project manager, I would first and foremost ensure my team understands the importance of time management and our specific role as the research team and how imperative our timeliness is because “shelf life” is a time constricted variable….   Read more»

]]> 999f3644c33f507e89cdb78edb0ff568 https://medicaldevicecourses.com/activity/p/21815/ Sat, 20 Mar 2021 07:42:53 -0400 Functional, project-based, and matrix are the three types of organizations. There are pros and cons to all three organizations, I’ll specify 2 of each: Functional pros: easy to coordinate within the department, and advancement positions are clear cut; cons: they…   Read more»

]]> 9c0e1a8b2f91ebf2bc382cc8cba65e29 https://medicaldevicecourses.com/activity/p/21814/ Sat, 20 Mar 2021 07:12:25 -0400 The severity of the recall depends on the company. In our everyday life, we can see where some companies chose to only send verification letters of the situation that lead to the recall, and they “suggest” that the consumer follow…   Read more»

]]> 26905d728968eec562f7a441ddfbcc41 https://medicaldevicecourses.com/activity/p/21811/ Sat, 20 Mar 2021 04:33:11 -0400 With your project life cycle sometimes depending on the project planning will continue almost through the entire project.  It is important to also understand that defining and planning go hand in hand for the cycle.  A very important piece of…   Read more»

]]> 16063cc5e466dfc630c09aa569ac87b5 https://medicaldevicecourses.com/activity/p/21687/ Sat, 13 Mar 2021 23:45:03 -0500 I agree that emotional intelligence is very important in order to be a successful leader, to often within some organizations, individuals are placed into leadership positions without the correct skill set to lead. Emotional intelligence is especially important during these…   Read more»

]]> 9511220901529f129c890ad3241462b0 https://medicaldevicecourses.com/activity/p/21620/ Tue, 09 Mar 2021 23:24:11 -0500 I chose oatmeal bath bars for children from kellerworks.com This falls under the FDAs category 1.  “In the second category, the product intended uses relate to sustaining or offering a general improvement to function while making reference to diseases or…   Read more»

]]> d08714dff26c44eb3cadb58329e2f4d0 https://medicaldevicecourses.com/activity/p/21619/ Tue, 09 Mar 2021 23:07:52 -0500 I agree that the primary objective in a business setting or project review should be to identify strengths and weaknesses of the project. However, I believe there has to be successful translation of the strengths and weaknesses identified in a project…   Read more»

]]> ffca43b4b83f365e685d599b387c64aa https://medicaldevicecourses.com/activity/p/21618/ Tue, 09 Mar 2021 22:56:39 -0500 Hello everyone,  I currently work in a “functional organization”. I work or the Department of Defense- the United States Army.  I work specifically for the United States Army Medical Command, it has been 13 years for this institution specifically. By…   Read more»

]]> d270e1ce4f54e1f8dff0e5884a582872 https://medicaldevicecourses.com/activity/p/21521/ Thu, 04 Mar 2021 23:05:26 -0500 Every good project manager has experience as a team member in some compacity. Some individuals luck up and are hired on with companies as project managers straight out of school but I believe most project managers have some sort of…   Read more»

]]> 80a0c2a98e6317095d0172942b984cd5 https://medicaldevicecourses.com/activity/p/21514/ Thu, 04 Mar 2021 07:23:44 -0500 Hello,  Yes, I do agree that competency is different from personality. I work within a federal agency and there is definitely a plethora of personalities within one organization with a great deal of red tape which at times make it…   Read more»

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