https://medicaldevicecourses.com/members/mejefferson/activity/ Activity feed for mejefferson. Sat, 25 Apr 2026 04:09:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 8a35530e3771babd7fcdc6b362eec117 https://medicaldevicecourses.com/activity/p/23693/ Mon, 11 Oct 2021 19:37:57 -0400 Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project according to their expertise/role. How would…   Read more»

]]> 5cdba4d70142097d5e9d05bff2c74927 https://medicaldevicecourses.com/activity/p/23692/ Mon, 11 Oct 2021 19:32:42 -0400 Posted by: @la82 The lectures introduce the three types of organizations. Project managers’ roles are specifically mentioned in both matrix and project-based organizations. While other posts discussed the preference of working under one or the other, no one mentions what…   Read more»

]]> 934169a609d3f884088aa53d74193916 https://medicaldevicecourses.com/activity/p/23691/ Mon, 11 Oct 2021 19:26:55 -0400 Posted by: @amd29 Quite recently Dr. Simon organized us into project teams. And strangely, I became a part of one before I knew it. The approach of forming the team was weird.Personally, after experiencing with the Functional Organizational type in…   Read more»

]]> 8f332646308b7f7010b737e931e00622 https://medicaldevicecourses.com/activity/p/23599/ Mon, 04 Oct 2021 15:49:36 -0400 Posted by: @abhitrivedi1211 What factors contribute to determining values for risk index numbers. Two examples are ‘how often the failure occurs’? and ‘what is the severity of the failure?’. There are several factors that contribute to determining values for risk…   Read more»

]]> 636ffafdf81ddffca0d4131054fc6b14 https://medicaldevicecourses.com/activity/p/23598/ Mon, 04 Oct 2021 15:30:22 -0400 Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   Read more»

]]> 644559cfda63c175623c2949440d950d https://medicaldevicecourses.com/activity/p/23597/ Mon, 04 Oct 2021 15:17:41 -0400 Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?  When dealing with risks, according to the FDA it is okay to use medical…   Read more»

]]> 097a2c12d42119c8a149ff3ded4753f9 https://medicaldevicecourses.com/activity/p/23510/ Mon, 27 Sep 2021 20:38:41 -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»

]]> e56547dc4e6ce9680dc45f4aa01170c6 https://medicaldevicecourses.com/activity/p/23509/ Mon, 27 Sep 2021 20:30:53 -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»

]]> ea26f9eaa5daf7b703583c78c082630b https://medicaldevicecourses.com/activity/p/23507/ Mon, 27 Sep 2021 20:17:53 -0400 Posted by: @la82 As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the process and if it is…   Read more»

]]> 1cbd2389637f147b8cf4b2314ace565b https://medicaldevicecourses.com/activity/p/23397/ Sun, 19 Sep 2021 23:33:57 -0400 During the current pandemic, there are over 100 vaccines being tested on humans worldwide. The average human today is a subject for a vaccine. Do you think that different vaccines may work on different people due to factors such as…   Read more»

]]> d7e369bd48e5d33e0b50227f88631e31 https://medicaldevicecourses.com/activity/p/23396/ Sun, 19 Sep 2021 23:24:21 -0400 Posted by: @savery115 Clinical trials and research is designed to expose a limited sample of subjects to potential new treatments. Human tests of a medical intervention typically pose risk to subjects despite the amount of laboratory and pre-clinical trails conducted…   Read more»

]]> f4ec2db3097271281e9345b49f13a995 https://medicaldevicecourses.com/activity/p/23395/ Sun, 19 Sep 2021 23:16:38 -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»

]]> 6f4a8b24ab497a338414091df4069b49 https://medicaldevicecourses.com/activity/p/23322/ Mon, 13 Sep 2021 14:03:18 -0400 Posted by: @sahitya-sadineni After reading through the article “Emotional Intelligence in Marketing Exchanges”, I found myself mostly agreeing with what the article was presenting. A high emotional intelligence can expand the business income inside an organization and can likewise reach…   Read more»

]]> f070b7affa3b410ce8029740a63e9e59 https://medicaldevicecourses.com/activity/p/23321/ Mon, 13 Sep 2021 13:52:41 -0400 Posted by: @manolo Dr. Simon touched upon Branding when going over the Facets of Marketing. The coloring is an important component to think about when branding a product/company. What kind of coloring do you notice companies are using and why…   Read more»

]]> bbfc3109a1f98e1ba7ace856d04e7b24 https://medicaldevicecourses.com/activity/p/23320/ Mon, 13 Sep 2021 13:42:42 -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»

]]> a6c5b73666138e0dacef091d9bb98fc7 https://medicaldevicecourses.com/activity/p/23181/ Mon, 06 Sep 2021 15:11:12 -0400 Posted by: @sahitya-sadineni Precision and accuracy are very important to the scientific field. Accuracy is how close the value is to a standard while precision refers to how close the values are. What roles do precision and accuracy play into…   Read more»

]]> 86d84c03f299c4eb88fd5bc00967861f https://medicaldevicecourses.com/activity/p/23180/ Mon, 06 Sep 2021 15:02:43 -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»

]]> b514960670e85336c84c155bf1036756 https://medicaldevicecourses.com/activity/p/23179/ Mon, 06 Sep 2021 14:41:32 -0400 The average medical device takes years to receive approval from the Food and Drug Administration. Devices have to go through many stages such as investigational device exemption, premarket notification, premarket approval application, down to the request for designation. The FDA…   Read more»

]]> e638c9a74178fb843b35af9ff3b42baf https://medicaldevicecourses.com/activity/p/23103/ Mon, 30 Aug 2021 21:46:41 -0400 Posted by: @tulikadasp When it comes to animal research there are various constraints we need to keep in mind. One of them is animal rights. A lot of animal rights group are against this. Recently there are few news about…   Read more»

]]> d765fe82946b2d843c1406c0bb3a39cb https://medicaldevicecourses.com/activity/p/23102/ Mon, 30 Aug 2021 21:27:28 -0400 Posted by: @savery115 I’ve never had the opportunity to conduct or be a part of a team doing pre-clinical / clinical research. For those of you who have done it in the past or are currently working in this type…   Read more»

]]> 3e48dc49c2893b0d1c1a78708f76911d https://medicaldevicecourses.com/activity/p/23101/ Mon, 30 Aug 2021 20:48:09 -0400 Posted by: @manolo In week one, Dr. Simon went over different aspects of working in Academia vs Industry. He asked us to make an argument for working in either option. As we start going into each role of Medical Device…   Read more»

]]> eae92feb69173ec316d493c786546575 https://medicaldevicecourses.com/activity/p/23079/ Fri, 27 Aug 2021 22:04:24 -0400 Posted by: @orleron As I said in the lecture for this module, this course is different. Whereas most courses seek to fill you with academic information in order to create a knowledge base for yourself, this course seeks to lay…   Read more»

]]> acfb724bb4ad012a6b5a9fc1e7857560 https://medicaldevicecourses.com/activity/p/23078/ Fri, 27 Aug 2021 21:44:26 -0400 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 medical device design…   Read more»

]]> 337ed3fe84de672195ca1c2b49609acc https://medicaldevicecourses.com/activity/p/22992/ Mon, 16 Aug 2021 22:45:44 -0400 Posted by: @ka-kyung-kim I have one scenario I wonder about what happens in this caseIn human resource management, a team has been settled and worked on a project and in the middle of the process. The project should keep moving…   Read more»

]]> edff042ee44f7b95bb7a007a8cca66c0 https://medicaldevicecourses.com/activity/p/22991/ Mon, 16 Aug 2021 22:34:01 -0400 Posted by: @aasutosh-purohit In the lecture we studied about Quality Assurance and Quality control. How these both are different from each other? There are many differences between quality control and quality assurance. QC focuses on fulfilling quality requirements and to…   Read more»

]]> ce90915a078e0d11f2a2b9c4ff5bce7a https://medicaldevicecourses.com/activity/p/22987/ Sun, 15 Aug 2021 16:00:34 -0400 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 to become a…   Read more»

]]> 70c4aa42e5739ebd3ff14c9fd6b05fff https://medicaldevicecourses.com/activity/p/22986/ Thu, 12 Aug 2021 20:43:02 -0400 Stakeholders typically invest in projects that they see will have potential in bringing more money than they invest in. Outside of monitoring the finances throughout the project, do you think stakeholders should be involved with the project as far as…   Read more»

]]> 1e8b34c7d26781607748b2b5724ea0d6 https://medicaldevicecourses.com/activity/p/22985/ Thu, 12 Aug 2021 20:34:44 -0400 In my opinion, every process involved in project management, from the initiation phase to the closing phase is just as equally important as the other. During initiation, you are trying to turn an idea into a goal. One simple idea…   Read more»

]]> e0acf72107772763e06d51e8ff86967b https://medicaldevicecourses.com/activity/p/22977/ Mon, 09 Aug 2021 00:42:32 -0400 Although every technique in the monitoring and controlling phase is important, I believe that the approval or rejection change makes or breaks the project. Suppose a PM approves of a medical device that still has potential hazards that were possibly…   Read more»

]]> b304b4274631b354beeaf7bb6ec05059 https://medicaldevicecourses.com/activity/p/22966/ Tue, 03 Aug 2021 20:28:34 -0400 Posted by: @rgp29 In this week’s lecture Dr. Simon mentioned that during the executing process of a project, the project manager (PM) is in charge of the source selection. This means the PM must decide on who are the appropriate…   Read more»

]]> 794d8fbf7d1bfc5e33249f3cb89eef7c https://medicaldevicecourses.com/activity/p/22965/ Mon, 02 Aug 2021 20:43:03 -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»

]]> 8d385e97af96046b7d8d81cb79e65d2b https://medicaldevicecourses.com/activity/p/22964/ Mon, 02 Aug 2021 20:26:04 -0400 Posted by: @ap962 This weeks lecture talks about project planning and execution. As a Project Manager, what are the key factors that need to be taken into consideration for a successful project execution?Also, what factors you would as a Manager…   Read more»

]]> a141ffdf5d4eceaf454f5e22fa9ded41 https://medicaldevicecourses.com/activity/p/22947/ Wed, 28 Jul 2021 20:40:35 -0400 Posted by: @talha-chaudhry One of the interesting things that Dr. Simon mentioned in this weeks lecture was the concept of team development. When you are a project manager, your project team is not composed of robotic entities. They are human…   Read more»

]]> 65a7862d47c401ab41fb3b91433e4f38 https://medicaldevicecourses.com/activity/p/22946/ Tue, 27 Jul 2021 20:02:50 -0400 Posted by: @devarshi-joshi If we talk about planning phase in a project of medical devices, according to me one of the important aspect is to find out user needs. Sometimes user needs are bit vague and ambigious but that is…   Read more»

]]> 568ca67fd823c10aaa5b093660da76b9 https://medicaldevicecourses.com/activity/p/22942/ Mon, 26 Jul 2021 18:41:01 -0400 During the planning phase of project management, both time and money are crucial. Timewise, the longer your product takes to develop, the more money you will have to seek from investors yet your product will have a higher potential to…   Read more»

]]> 4bccf5f23f10f3b7a2fbce2d6b800667 https://medicaldevicecourses.com/activity/p/22931/ Wed, 21 Jul 2021 18:05:35 -0400 Posted by: @aasutosh-purohit we know that in Project scheduling or task scheduling, the following are the steps needed:Defining Activities, doing proper Estimates, determining Dependencies and assigning Resources. According to you guys, are there any other factors that need to be…   Read more»

]]> a6403bf9d6fe8ad240b9bdbe3fb82a19 https://medicaldevicecourses.com/activity/p/22930/ Tue, 20 Jul 2021 20:18:16 -0400 There are quite a few methods that a project manager can develop in order to assist employees to  complete tasks in timely manner. Depending on the project, doing research on previous related projects is one thing that can be used…   Read more»

]]> 3a3f200eab98e2d3cbeebf03aef18509 https://medicaldevicecourses.com/activity/p/22928/ Mon, 19 Jul 2021 20:53:51 -0400 Posted by: @ryanrattazzi In the lecture slides this week, we learned about all things risk management. Starting in the planning phase, a part of DDP is to do risk analysis to determine the probability some undesired consequence will occur in…   Read more»

]]> d97be4dcb55abd81b7b95b33df3338b6 https://medicaldevicecourses.com/activity/p/22913/ Wed, 14 Jul 2021 17:53:32 -0400 Believe it or not, there are many differences between a project manager and a clinical project manager. Project managers take on several roles such as planning what work needs to be done, when and who’s going to do it, looking…   Read more»

]]> 311d43fc3df4413facb626f41a8071b5 https://medicaldevicecourses.com/activity/p/22911/ Tue, 13 Jul 2021 18:00:20 -0400 Being organized is key to completing any task successfully. As a lab technician, keeping up to 300 chemicals in alphabetical order helps to work at a faster pace. When making batches of media such as broths and agar, instead of…   Read more»

]]> 274fc95964c511c2cb57e87ca6c79f93 https://medicaldevicecourses.com/activity/p/22905/ Mon, 12 Jul 2021 18:47:33 -0400 Amongst the three types of organizations discussed in this weeks lecture, functional, project-based, and matrix, all of these have one thing in common which is a chief executive, functional manager, project manager, both, and lastly the staff members. In the…   Read more»

]]> e824c617b0165ed1193eaaeb473978cb https://medicaldevicecourses.com/activity/p/22888/ Wed, 07 Jul 2021 19:49:35 -0400 Risk management is important because you never know how projects may turn out amongst the many sectors that are involved. To avoid uncertainties and minimizing possible occurrences, creating a Risk Management Plan is a necessity. A Risk Management Plan (RMP)…   Read more»

]]> c708e1002882a825663a11f72791ca4d https://medicaldevicecourses.com/activity/p/22884/ Wed, 07 Jul 2021 11:26:20 -0400 Posted by: @ap962 As well know, all medical devices require approval so that they can be used.What do you think happens in the case of an emergency? Can a physician use an unapproved device, if it has the potential to…   Read more»

]]> 461a2ee7ffb834f8d89c66583a59880c https://medicaldevicecourses.com/activity/p/22883/ Tue, 06 Jul 2021 17:42:53 -0400 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 safe, effective and…   Read more»

]]> 35539b43fbb49f224cbeb7385cfb01f6 https://medicaldevicecourses.com/activity/p/22864/ Fri, 02 Jul 2021 18:41:31 -0400 First and foremost, I appreciate the fact that emotional intelligence is considered and taken seriously in project management. As you stated, it can make or break a team which is absolutely correct. I have had quite a few experiences where…   Read more»

]]> 017d365d89779e8e615cbbd753585dd3 https://medicaldevicecourses.com/activity/p/22863/ Fri, 02 Jul 2021 18:25:33 -0400 Communication is the basis to every project in my opinion. Any time a project fails, it is usually due to miscommunication. Financial, scientific data, and even errors in time management can be avoided if a team simply devotes to staying…   Read more»

]]> 17c898756b49405ad3dc86de9ae51c0a https://medicaldevicecourses.com/activity/p/22853/ Wed, 30 Jun 2021 20:22:55 -0400 Posted by: @hruship101 During a project, we set milestones to achieve. However, due to certain circumstances, we cannot meet the deadline that results in missing a milestone. Missing a milestone can be either a failure by the team or it…   Read more»

]]> c54ecfbe3dff8891830f51f8165c0da1 https://medicaldevicecourses.com/activity/p/22852/ Wed, 30 Jun 2021 20:01:17 -0400 Posted by: @kbentleymsm-edu Consider the three types of organizations in project management: functional, project-based, and matrix.  Which of those formats do you think you would most like to work under?  Explain.   I personally would like to work under the…   Read more»

]]> ec4875c570463904fc6d9e0a4fac1192 https://medicaldevicecourses.com/activity/p/22829/ Tue, 29 Jun 2021 15:43:04 -0400 0