https://medicaldevicecourses.com/members/nr473/activity/ Activity feed for nr473. Fri, 24 Apr 2026 16:55:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 40d45bb54ccb4fb68f1d2f5f6f488496 https://medicaldevicecourses.com/activity/p/22367/ Sun, 02 May 2021 01:59:03 -0400 The hiring process is one of the most important parts of retention. A good fit does not always mean the one person with the highest qualifications on paper.  Suitability for the position has to be analyzed. A couple of extra…   Read more»

]]> d62dfbae490a3cabb411ac1d90f8d0e8 https://medicaldevicecourses.com/activity/p/22365/ Sun, 02 May 2021 01:28:32 -0400 My aim is to be a scientist. But I think that it is totally wrong to believe that only managers will require managerial skills. Scientists also will have to lead laboratories, meet deadlines and take up projects. Good management of…   Read more»

]]> 2f034c6b4bf2c92fe608629c22b220d1 https://medicaldevicecourses.com/activity/p/22363/ Sun, 02 May 2021 00:57:43 -0400 I personally believe that I am acceptably organized. But I am very novice when it comes to social interactions. Throughout my studies and career, I have always been on the technical end and did not have many opportunities to interact…   Read more»

]]> 3adf2762fbb221349a7ec936bb298432 https://medicaldevicecourses.com/activity/p/22213/ Tue, 20 Apr 2021 06:08:12 -0400 What motivates me the most is to see people believe in me. I know that this is not as good as self-motivation, but still, that is what has worked for me so far. I sometimes find it hard to work…   Read more»

]]> 55f343a6cb4d538ff71896d194dc3770 https://medicaldevicecourses.com/activity/p/22212/ Tue, 20 Apr 2021 05:49:52 -0400 It is known from numerous studies that only a small percentage of new hires fail to succeed due to a lack of knowledge or technical skills. At the same time, several studies exist that show that higher performers tend to…   Read more»

]]> 6a3e209cb01c56e1388c913ca5dd0bbd https://medicaldevicecourses.com/activity/p/22211/ Tue, 20 Apr 2021 05:30:08 -0400 I think we are biased towards thinking of one thing at a time. In college, we focus on one field of study and we spend a whole lot of time thinking only of that particular thing. So, I think all…   Read more»

]]> 4362e5c38cb4868f3a30d7b8f89cb6e2 https://medicaldevicecourses.com/activity/p/22108/ Tue, 13 Apr 2021 21:43:58 -0400 Reactive management can happen due to a crisis or unexpected situation arising in the company. But a habitual reactive management style is not that good. Reactive management tends to result sometimes in poor quality also you may miss to identify…   Read more»

]]> 44d56bce8db19f7bd1bfe335cc145af3 https://medicaldevicecourses.com/activity/p/22104/ Tue, 13 Apr 2021 19:51:14 -0400 The risk management plan becomes a very important part of such situations. Having a substitute member trained on essential skills performed by a key player in the team is important. Also having appropriate contingency plans helps. Having identified each team…   Read more»

]]> 28e8b8fc6aefe4d90edfa359ba0d4150 https://medicaldevicecourses.com/activity/p/22103/ Tue, 13 Apr 2021 19:32:35 -0400 Six sigma is very popular as it reduces waste by minimizing variations in processes. In a bell curve distribution, 6 sigma ultimately means 3.4 defects for every one million opportunities, or in other words 99.99966% success.  Similarly, another method of…   Read more»

]]> 84a1f0e98df2a223ebe88ba552965da0 https://medicaldevicecourses.com/activity/p/22062/ Mon, 12 Apr 2021 00:53:30 -0400 This is my first class with Dr. Simon. I had taken a course in project management and another course in production planning and control from my home school in Sri Lanka. But this the very first time that I am…   Read more»

]]> eb455ba686f54dd336142857d715e7fe https://medicaldevicecourses.com/activity/p/22057/ Mon, 12 Apr 2021 00:36:55 -0400 As many have already described the steps that happen during the closing phase I would like to discuss the importance of the closing phase in a project. At first, the project closure might seem like an obvious and effortless phase…   Read more»

]]> b655b6f3e254336ef0edbc1aaa9a47ad https://medicaldevicecourses.com/activity/p/22047/ Sun, 11 Apr 2021 22:50:03 -0400 Risk management and agile project management are two things that come to my mind when thinking of cost overruns. In most cases, cost overruns occur due to unexpected expenditures which most of the time are resulting from unassessed risks in…   Read more»

]]> 8718950d33938ef90e442a51ac4a09dd https://medicaldevicecourses.com/activity/p/21873/ Fri, 26 Mar 2021 23:27:58 -0400 To add to the discussion on Gantt charts I would like to discuss a little about the history. Henry Laurence Gantt who was an American mechanical engineer is credited with the invention of the Gantt chart. It was introduced by…   Read more»

]]> b3dcabeadd9c17ab439a7e8f037409ba https://medicaldevicecourses.com/activity/p/21863/ Fri, 26 Mar 2021 14:53:57 -0400 If the change involves the device or the manufacturing of the device, the technical aspects of the change have to be reviewed. The most important factor will be making sure that patient health and safety will not be impacted in…   Read more»

]]> 8bf5b7a7410fd0531732f8dd60201003 https://medicaldevicecourses.com/activity/p/21862/ Fri, 26 Mar 2021 03:29:45 -0400 It is very important to understand the product ecosystem. The tests have to start to be designed as product specs are being developed. The tests have to be treated like a subproject. While defining the acceptance criteria ensuring there is…   Read more»

]]> 73137dc7144d8b49236817bd731b205a https://medicaldevicecourses.com/activity/p/21531/ Sat, 06 Mar 2021 04:08:36 -0500 Sometimes milestones are missed when there is project scope change, in this case, it is vital to start realizing that the defined scope should be reclarified and roles and responsibilities should be reiterated to make sure that there is no…   Read more»

]]> cd382474c581454ff902ad2ef9f0fece https://medicaldevicecourses.com/activity/p/21530/ Sat, 06 Mar 2021 03:55:23 -0500 A good starting point might be to check whether your test conditions are just too strict, what if over-verification is performed. I think that it is always valid to ask yourself after a test failure whether that test was absolutely…   Read more»

]]> 93a89a13b845199dd7fac8e878eb7543 https://medicaldevicecourses.com/activity/p/21435/ Tue, 23 Feb 2021 17:54:39 -0500 Understanding the requirements and establishing a robust project definition is paramount for the success of the project. Spending more time on the initiation and planning phases is a long time investment and should be encouraged by the PM and high-level…   Read more»

]]> 63172eaa451195d59c484be0f9f0cdb9 https://medicaldevicecourses.com/activity/p/21406/ Mon, 22 Feb 2021 03:30:38 -0500 Earned Value Management highly depends on quantitative project planning. This is not practical for some novel and agile projects. Some modern projects which are always open to change utilize methods such as scrum or agileEVM. EVM also has other limitations…   Read more»

]]> 65e2b7cb16a85ca0c8c9d73565cd606b https://medicaldevicecourses.com/activity/p/21389/ Sun, 21 Feb 2021 21:23:26 -0500 In addition to fault tree analysis and FMECA which are widely used, revealing severe hazard potential as early as possible is very important. Preliminary hazard analysis conducted as early as in the conceptual design stage could help save time and…   Read more»

]]> 206da3cb777dd4d32a33efd640411c47 https://medicaldevicecourses.com/activity/p/21374/ Sat, 20 Feb 2021 02:18:19 -0500 As I do not have any experience to share here, I would like to discuss a few new terms related to the topic. The tendency of an organization or group to take risks in a given situation can be termed…   Read more»

]]> 0c4ea56fc765ceeaa985ec7b2759d697 https://medicaldevicecourses.com/activity/p/21356/ Mon, 15 Feb 2021 03:03:48 -0500 I can recall a machine design project from college where we had to design a Cam Tester together as a total class. In the beginning, bringing everyone together was a hard job for the team leader. Everyone had different opinions,…   Read more»

]]> b9a711ab207865a84e449616bb9e36a5 https://medicaldevicecourses.com/activity/p/21353/ Mon, 15 Feb 2021 01:31:27 -0500 Being a project manager in the medical device industry requires being able to cope with ambiguity and the ability to be able to handle constraints in budget, scope, and time. Most of the projects will require cross-functional operations. Therefore while…   Read more»

]]> ed3b1d3ac7c72e67c960a005878f660c https://medicaldevicecourses.com/activity/p/21340/ Sat, 13 Feb 2021 20:01:44 -0500 Procedures need to be established and maintained by the company to document design changes. This is a requirement of the FDA. These procedures have to cover both direct design changes (these are set down through Document control) and verification deficiencies…   Read more»

]]> f5eb9db050678f8832b335c4b3d65c99 https://medicaldevicecourses.com/activity/p/21268/ Thu, 04 Feb 2021 17:42:01 -0500 As various interpersonal skills and traits of a good project manager have already been well discussed in this topic I would like to introduce some management strategies that project managers can follow based on the context.  Authoritative – In this…   Read more»

]]> c5e251367cf2f4eb2f026e812075cd4c https://medicaldevicecourses.com/activity/p/21267/ Thu, 04 Feb 2021 17:11:58 -0500 About 47 percent of authorized devices in the market are class 1 devices. These devices should comply with general Controls (the basic provisions (authorities) of the May 28, 1976 Medical Device Amendments). The general controls include the provisions of the…   Read more»

]]> 4c1881b8361d1fba74219651e8e984a3 https://medicaldevicecourses.com/activity/p/21266/ Thu, 04 Feb 2021 16:14:46 -0500 The project management approach highly depends on what type of organization it is, and so identifying the suitable type of organization is crucial for project success. The authority given to the project manager varies across organization types. In project-based organizations…   Read more»

]]> f3d973406b2e4ded51187f03679fa583 https://medicaldevicecourses.com/activity/p/21223/ Sun, 31 Jan 2021 18:52:24 -0500 In 2017, 82 percent of total devices cleared by CDRH were through the 510(k) pathway and so the importance of keeping the 510(k) updated is very clear. In recent years the FDA recognized the importance and has worked on establishing a…   Read more»

]]> 9c59694190088980e6b6d399f6292c53 https://medicaldevicecourses.com/activity/p/21216/ Sun, 31 Jan 2021 08:08:58 -0500 Project management is, for the most part, less of a science and more of art. Therefore, I believe that categorizing or formalizing the practices in project management is extremely difficult and unifying even more. The point of view is that…   Read more»

]]> 4c9f2fad107c1868ca1defb552bbb1d8 https://medicaldevicecourses.com/activity/p/21215/ Sat, 30 Jan 2021 21:44:06 -0500 As the hearing aids used in your project would fall under the category of regulated medical devices (as they would be in section 201(h) of the FD&C Act and cleared as already in the market) and as the developed app…   Read more»

]]> a32df27864c440be53a8c899f64809f8 https://medicaldevicecourses.com/activity/p/21174/ Mon, 25 Jan 2021 14:50:39 -0500 I have not had much experience working in industry settings. But I think that I can share a brief experience I had at Brandix apparel solutions limited during a three-month internship. I and a colleague of mine were recruited from…   Read more»

]]> 1e36cfcb38ebffa1df943c5a0436ec08 https://medicaldevicecourses.com/activity/p/21173/ Mon, 25 Jan 2021 14:50:39 -0500 Following up smartly is a necessary management skill, and with the pandemic, it has even become more important. Adding coworkers of the recipient as CC to an email sometimes helps in receiving a quick response. I personally like to receive…   Read more»

]]> e818a1fd648cff22653c9e64526d34e5 https://medicaldevicecourses.com/activity/p/21172/ Mon, 25 Jan 2021 14:50:31 -0500 45e1d8f2097f104dbadb28c72cf2c4e2 https://medicaldevicecourses.com/activity/p/21156/ Mon, 25 Jan 2021 14:50:08 -0500 In the context project management I think that validation and subsequent verification have to be carried out by the project management team throughout the total project and not at a particular time. Validation and verification essentially make sure that the…   Read more»

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