https://medicaldevicecourses.com/members/srg36/activity/mentions/ Activity feed mentioning srg36. Fri, 24 Apr 2026 18:57:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 8f579f703965e6ddb46420edc1554fb1 https://medicaldevicecourses.com/activity/p/26257/ Thu, 28 Jul 2022 00:29:28 -0400 @srg36 I think that placebos are absolutely necessary for clinical trials to study human research and development in gaining greater advancement in drug trials and to see if a drug is actually as effective as produced by the FDA approval….   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»

]]> 87a30f4b644a55cd78f422bd60ecf656 https://medicaldevicecourses.com/activity/p/23365/ Sat, 18 Sep 2021 12:36:23 -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»

]]> 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»

]]> c1b58fa0925a201ce396829a316d16c1 https://medicaldevicecourses.com/activity/p/22846/ Wed, 30 Jun 2021 18:13:17 -0400 Posted by: @srg36 I’m wondering if any of you have experience working on a project where there were multiple project managers who each were responsible for different portions of the project rather than just one project manager who managed the…   Read more»

]]> 4242255e631e56ac147071fc1b7fb2ae https://medicaldevicecourses.com/activity/p/22555/ Sat, 29 May 2021 23:57:15 -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»

]]> 94ae1d8dd1f04f8b66c1c7adbab636e7 https://medicaldevicecourses.com/activity/p/22546/ Tue, 25 May 2021 16:38:43 -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»

]]> 194edcd5c8e54117c1114d07504f1406 https://medicaldevicecourses.com/activity/p/22429/ Sun, 09 May 2021 19:24:27 -0400 Posted by: @srg36 I’m wondering if any of you have experience working on a project where there were multiple project managers who each were responsible for different portions of the project rather than just one project manager who managed the…   Read more»

]]> 98aa070cb1add6bb893df7f637e22c1f https://medicaldevicecourses.com/activity/p/21830/ Mon, 22 Mar 2021 01:37:54 -0400 Posted by: @srg36 I work within a matrix organization, but as Dr. Simon mentioned in his lecture about his experience with a previous company, I would label it as a weak matrix organization. The reason I would call it a…   Read more»

]]> 8d5a59a2090b15f9ee423477998c1d25 https://medicaldevicecourses.com/activity/p/21593/ Mon, 08 Mar 2021 04:21:54 -0500 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»

]]> 04ffb4656dfe5100bf6e4cac55c28da7 https://medicaldevicecourses.com/activity/p/21549/ Sun, 07 Mar 2021 22:50:49 -0500 I believe that returning to activities to an earlier phase is not necessarily a bad thing.  @srg36 mentioned, changes can happen due to unforeseeable events and I have seen that in the workplace. Returning to a previous state such as…   Read more»

]]> 4527ec62d8e50467501c5307c2c79aaa https://medicaldevicecourses.com/activity/p/20668/ Mon, 19 Oct 2020 00:49:51 -0400 Posted by: @srg36 I’m wondering if any of you have experience working on a project where there were multiple project managers who each were responsible for different portions of the project rather than just one project manager who managed the…   Read more»

]]> 09471b31b2684862c68bec940af37935 https://medicaldevicecourses.com/activity/p/19867/ Thu, 16 Apr 2020 00:02:51 -0400 @srg36 is correct. Single source is a little risky, but it is a necessary evil while launching a new product to market. The project team does not have enough time to on board a secondary source in most projects. To…   Read more»

]]> 61fa3d7e0c44aaceabcfd07b5c596f5c https://medicaldevicecourses.com/activity/p/15167/ Wed, 15 May 2019 19:03:38 -0400 I agree with @srg36 that even if you use project management tools like Pert charts, Gantt charts, there will still inevitably encounter pitfalls, but you will be able to more effectively manage these scenarios with these management tools. As Dr….   Read more»

]]> 91aac15461fcfdd0bf1fab5f23eda5c6 https://medicaldevicecourses.com/activity/p/15150/ Wed, 15 May 2019 19:03:28 -0400 I agree with @srg36 that the way to master the skill is a lot of practice and experience. I would like to add reading to that list. I took Technical Writing as an undergraduate course, I was good but not…   Read more»

]]> 42ffde785f4d1cd2aad01cb8f7c56354 https://medicaldevicecourses.com/activity/p/15078/ Wed, 15 May 2019 19:02:50 -0400 I disagree with @srg36 and agree with @alexandrabuga about the need to update revision number. I think it’s needed to have all the docs updated once a revision is made. I also agree that it’s a lot of work and…   Read more»

]]> a7e42b96fedef4ffa090ec70eee9be74 https://medicaldevicecourses.com/activity/p/14684/ Wed, 15 May 2019 18:59:10 -0400 Like @srg36, I found the 2005/50/EC directive about the reclassification of hip, shoulder and knee devices from Class IIb to Class III. I also found that in EU All implantable devices and long-term surgically invasive devices are in Class IIb…   Read more»

]]> 4426817d5a9db9b9196e9ad95c4fb88d https://medicaldevicecourses.com/activity/p/14554/ Wed, 15 May 2019 18:57:58 -0400 I agree with @srg36 and @cdj24 that the four categories are in order. Upper management is responsible for developing the strategic plan and how it can be executed. I agree that it can be frustrating for upper management to make…   Read more»

]]> d05fafb5f9751d9579c67072948071f4 https://medicaldevicecourses.com/activity/p/13738/ Wed, 15 May 2019 17:07:47 -0400 @srg36 there is a difference between inventorship and ownership. Even if an employee comes up with an invention at most hospitals and research institutions you assign you rights to the employer. This is actually usually included when you sign your…   Read more»

]]> af253f294c9c63303d145538331079b7 https://medicaldevicecourses.com/activity/p/13656/ Wed, 15 May 2019 17:06:58 -0400 I agree with @srg36 that placebos are very important. The expectation is a very powerful thing. Similar to the example Dr. Simon mentioned in the lecture, sometimes, when people call to make an appointment with a doctor/therapist, they already feel…   Read more»

]]> d9c538f4a54f575823dc4a48fc37d208 https://medicaldevicecourses.com/activity/p/13265/ Wed, 15 May 2019 17:03:24 -0400 I agree with @srg36 about the nuances when it comes to quality control. Quality assurance process and quality control processes are crucial for any company/organization. In fact, it’s so important that it should be paid attention carefully and fully invested…   Read more»

]]> ac040ff3d7f98aec2bd66b4d417b6982 https://medicaldevicecourses.com/activity/p/13072/ Wed, 15 May 2019 17:01:43 -0400 Adding to @srg36, De Novo means an application sent by the medical device sponsor to FDA. So it establishes a new “device type” along with classification, regulation, necessary controls and product code, and it is eligible to serve as a…   Read more»

]]> c2a2ffb4dfd85c81cdbb7904c5d1633c https://medicaldevicecourses.com/activity/p/13071/ Wed, 15 May 2019 17:01:42 -0400 @Srg36 did a great job of summarizing the de Novo classification process and ruling. I agree that this deNovo classification process is beneficial because previously having an automatic Class III determination and to submit to have down classed to Class…   Read more»

]]> 2d773c11a5ea0688a31b2b805c7e42f0 https://medicaldevicecourses.com/activity/p/6471/ Sat, 24 Feb 2018 18:18:04 -0500 I agree with @srg36 that even if you use project management tools like Pert charts, Gantt charts, there will still inevitably encounter pitfalls, but you will be able to more effectively manage these scenarios with these management tools. As Dr. Simon mentions in lecture, it is important not only to schedule the tasks but to account for costs and…[Read more]

]]> 0 ffed5119d28e776f016855eafe2874e8 https://medicaldevicecourses.com/activity/p/6454/ Fri, 23 Feb 2018 13:43:28 -0500 I agree with @srg36 that the way to master the skill is a lot of practice and experience. I would like to add reading to that list. I took Technical Writing as an undergraduate course, I was good but not essential. Nobody was really in my field then and the teacher tried to generalized all students so they could only provide the structure but not…[Read more]

]]> 0 6f18846c42e08441a93ffb68d0909f80 https://medicaldevicecourses.com/activity/p/6374/ Sun, 18 Feb 2018 22:18:19 -0500 I disagree with @srg36 and agree with @alexandrabuga about the need to update revision number. I think it’s needed to have all the docs updated once a revision is made. I also agree that it’s a lot of work and sometimes tedious to chase these related docs. An automated updating system can be a huge help. I found this Medical Device Document…[Read more]

]]> 0 248f7c1d63441fcb4e466a5feca40209 https://medicaldevicecourses.com/activity/p/5979/ Mon, 29 Jan 2018 02:49:43 -0500 I agree with opinions stated above. I believe the major challenge facing medical device regulators as well as manufacturer comes down to differentiating between combination devices that are primarily devices and those that are medicinal. This will even get harders with the adoption of new technologies such as bioelectronics because they could both…[Read more]

]]> 0 67233140d3408c42e3d87a205c171fb7 https://medicaldevicecourses.com/activity/p/5922/ Sun, 28 Jan 2018 17:58:51 -0500 Like @srg36, I found the 2005/50/EC directive about the reclassification of hip, shoulder and knee devices from Class IIb to Class III. I also found that in EU All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended: to be placed in the teeth, in which case they are in Class IIa, – to be used…[Read more]

]]> 0 aed50c9b6f2fbe510b0784cdcb4aedb9 https://medicaldevicecourses.com/activity/p/5675/ Sun, 21 Jan 2018 20:04:11 -0500 I agree with @srg36 and @cdj24 that the four categories are in order. Upper management is responsible for developing the strategic plan and how it can be executed. I agree that it can be frustrating for upper management to make these decisions without having input from the Project/Portfolio managers who will end up doing the work, but the reality…[Read more]

]]> 0 6306fe965a7a0d1bb3ae4c9fae63b389 https://medicaldevicecourses.com/activity/p/4599/ Sun, 29 Oct 2017 20:34:27 -0400 @srg36 there is a difference between inventorship and ownership. Even if an employee comes up with an invention at most hospitals and research institutions you assign you rights to the employer. This is actually usually included when you sign your employee agreement on your first day with HR. At sloan, if you create an invention while you’re an…[Read more]

]]> 0 78ac63b86a922a522bf53129bebaeb02 https://medicaldevicecourses.com/activity/p/4377/ Tue, 24 Oct 2017 17:35:12 -0400 I agree with @srg36 that placebos are very important. The expectation is a very powerful thing. Similar to the example Dr. Simon mentioned in the lecture, sometimes, when people call to make an appointment with a doctor/therapist, they already feel better even before they see the doctor/therapist. Another point I want to point out is that in most…[Read more]

]]> 0 9e929a52b9e7acb70d15bc547ad89e70 https://medicaldevicecourses.com/activity/p/3884/ Sat, 07 Oct 2017 02:37:13 -0400 I agree with @srg36 about the nuances when it comes to quality control. Quality assurance process and quality control processes are crucial for any company/organization. In fact, it’s so important that it should be paid attention carefully and fully invested so that it function as efficiently as possible. For example: hiring the best people…[Read more]

]]> 0 96c957ad23517f245c4a59ee07027991 https://medicaldevicecourses.com/activity/p/3540/ Tue, 26 Sep 2017 03:30:34 -0400 Adding to @srg36, De Novo means an application sent by the medical device sponsor to FDA. So it establishes a new “device type” along with classification, regulation, necessary controls and product code, and it is eligible to serve as a predicate for new medical devices, where appropriate 510k process. So instead of going through 510k process…[Read more]

]]> 0 3a1615c4da9e01fe991e036639fe5ecd https://medicaldevicecourses.com/activity/p/3539/ Tue, 26 Sep 2017 02:03:10 -0400 @Srg36 did a great job of summarizing the de Novo classification process and ruling. I agree that this deNovo classification process is beneficial because previously having an automatic Class III determination and to submit to have down classed to Class I or II is inefficient. Having the deNovo process is both time and money saving for both the…[Read more]

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