https://medicaldevicecourses.com/members/ial4/activity/ Activity feed for ial4. Fri, 24 Apr 2026 18:41:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 fcd6b91ff7330fe143051ee7d567cb49 https://medicaldevicecourses.com/activity/p/15977/ Wed, 15 May 2019 19:15:49 -0400 As posted above, after graduation everyone need to gain experience and enter into manger role. I am working for a big organization for 6 months now . I also have engineers who is experienced for 25 years. They have all…   Read more»

]]> 23304410d28868d6d312419edaa18d0a https://medicaldevicecourses.com/activity/p/15976/ Wed, 15 May 2019 19:15:49 -0400 Project management team can be big and small depends on the organization , project work ,resources, knowledge skill ect. Team can be big or small they ultimate aim is reach project scope and description.

]]> 0447e9d0254e96b027cfa3a2ad1fd276 https://medicaldevicecourses.com/activity/p/15975/ Wed, 15 May 2019 19:15:48 -0400 Project managers have a great role in motivating the tram members. When a leader defines the purpose, vision and value , you articulate a set of principle that focus your efforts and guide you in making choices, interacting with others,and…   Read more»

]]> 0fdabe19d09b8f1a1dc33ad87bc8d076 https://medicaldevicecourses.com/activity/p/15850/ Wed, 15 May 2019 19:14:33 -0400 Studies says that factor that help retention are Meaningful work, Compensation and pride in the organization. When does it mean by these factor. By having a meaningful work : people stay when their daily work matches their talents and interests,…   Read more»

]]> f14064e3700830e3f3655bc266ac91e6 https://medicaldevicecourses.com/activity/p/15849/ Wed, 15 May 2019 19:14:32 -0400 Even if your job is challenging , you may quit that job or you may feel demotivated because of lack of appreciation or recognition you get for the work you completed so far. so appreciation has an important role in…   Read more»

]]> ebba4090289d0d5f13cbb8424e2e0311 https://medicaldevicecourses.com/activity/p/15831/ Wed, 15 May 2019 19:14:23 -0400 As agree with most of the discussion above . The most important thing that motivates me is the career growth and development that i get. Every year my manger evaluate our performance, they provide us with training that we can…   Read more»

]]> ad6ede1fb77d6b8b1d8660a8f81fb8cf https://medicaldevicecourses.com/activity/p/15744/ Wed, 15 May 2019 19:13:29 -0400 WBS is very important for a project. Its the initial planning part that the group performs together.If there is a difficult in properly identifying the WBS, it can affect the remaining part of the PM process.Some of the WBS Pitfalls…   Read more»

]]> 12f481e7a86f952072e4932a9934b8c4 https://medicaldevicecourses.com/activity/p/15725/ Wed, 15 May 2019 19:13:18 -0400 Hello, Communication is very important in an organization. According to my current site manager, Transparency between different site/organization site is very important. what He meant by transparency is that we need to communicate. There should be a good flow of…   Read more»

]]> e97d441bab0a55cda889e0ae37e504a1 https://medicaldevicecourses.com/activity/p/15720/ Wed, 15 May 2019 19:13:15 -0400 Finding the right person, and fit them to the need is very important for a successful organization. Checking the performace report and update there knowledge and skill to the current development is very important for a organization. For an employee…   Read more»

]]> 0f203c5a75624ea93aeaa27e1109116d https://medicaldevicecourses.com/activity/p/15599/ Wed, 15 May 2019 19:08:06 -0400 I agree with your discussion, Along with that it will provide a status of the company in terms of growth. How it will be in coming years .

]]> 41197fcafef127d2e3fe2d6984c82d63 https://medicaldevicecourses.com/activity/p/15598/ Wed, 15 May 2019 19:08:05 -0400 Factors other than matrix that can help detect the status of project is a detailed information system . If we communicate good regarding our project detail it will help us understand the growth o the project or status of the…   Read more»

]]> 7500c3f497e4beda93915c6b8056e1cd https://medicaldevicecourses.com/activity/p/15497/ Wed, 15 May 2019 19:07:00 -0400 I agree with the discussion. I had a situation in one of my project that i a worked with at the beginning of my career. I was in the quality control department, where we test some required number of batches…   Read more»

]]> e91512d011cf4c553b81213eae054103 https://medicaldevicecourses.com/activity/p/15485/ Wed, 15 May 2019 19:06:52 -0400 I don’t have much experience in Engineering change order. Thank you SMK45 for sharing your experience.From my research i found the stages of the engineering change process are 1. Issue identification & scoping 2. ECR creation: An engineering change request…   Read more»

]]> 55e8fd0bed3a5bb5b88087c562f5eede https://medicaldevicecourses.com/activity/p/15442/ Wed, 15 May 2019 19:06:25 -0400 Budgets, Quality checks and milestones are the basic components of a project control system. To use them 1.Focus on what is most important .Which parts of the project are the most crucial to track and control? where are the essential…   Read more»

]]> bcca9f8aa56703fd2a48fca3353f77fe https://medicaldevicecourses.com/activity/p/15381/ Wed, 15 May 2019 19:05:46 -0400 FDA recognize that timely Pre-market reviews also depends on the timely and effective review consultations and collaborations between and among centers. For this reason, the Agency has established a standard operating procedure for the the Inter center consultative/collaborative review process…   Read more»

]]> 2a90a96fc18c58082af8d949588d63ba https://medicaldevicecourses.com/activity/p/15378/ Wed, 15 May 2019 19:05:44 -0400 In the simulation , We can have people of different approach.As a project manager we need to understand each situation of the project. ‘Transparency’ is really important for a successful project. we can have a project team of different power,…   Read more»

]]> 6d7b933c3f71483ba66942cd57cb9e73 https://medicaldevicecourses.com/activity/p/15375/ Wed, 15 May 2019 19:05:42 -0400 I have not worked for a medical device company . But i worked for a drug company for 2 years. Scope creep can occur, in my case we had to start all over again. We used to make Morphine control…   Read more»

]]> 3694938321fb14e418a4b93b89f73600 https://medicaldevicecourses.com/activity/p/15310/ Wed, 15 May 2019 19:05:06 -0400 I agree with the discussion above . I would like to mention that we need a use the tools for scheduling. Instead to making a false things that you can schedule it by your own skills. We need to use…   Read more»

]]> b2395c04a18236f13db46754482ac6c3 https://medicaldevicecourses.com/activity/p/15285/ Wed, 15 May 2019 19:04:50 -0400 I agree with the discussion mentioned by smk45. Gantt chart gives a visual detail of what is going on in a project.what stage are we in ? how long it take to finish that stage.It help to manage project issue…   Read more»

]]> 5f24e9ad6af04ebfb1969d896803c25b https://medicaldevicecourses.com/activity/p/15280/ Wed, 15 May 2019 19:04:47 -0400 I agree with the discussion above . Each phase is important. Planning has have to determine the real problem , identify stakeholders, define project objectives. There are many problem that a project fall into they are . The problems they…   Read more»

]]> 0f59f3138e1a14882ade5222ce468ee5 https://medicaldevicecourses.com/activity/p/15146/ Wed, 15 May 2019 19:03:26 -0400 Hello, I agree with your thought, but it can’t happen all the time . Mangers use several different kinds of tools to create draft schedules .These include bar charts, flow charts, and PERT charts.I will discusses in detail below. Bar…   Read more»

]]> 881f2fd2d21fc0286679ecde4bac3e16 https://medicaldevicecourses.com/activity/p/15140/ Wed, 15 May 2019 19:03:23 -0400 I agree with the discussion above. By integrating six sigma to the project planning phase seeks to improve the output of the process by identifying and removing the causes of defects and minimizing variability in the business process. It uses…   Read more»

]]> f0ae0afcc58f9b72fbf617f722f8c230 https://medicaldevicecourses.com/activity/p/15032/ Wed, 15 May 2019 19:02:27 -0400 Hello , As the discussion about mentioned about a project is initiating ,but it is really important to understand responsibility of each members in the project in order to run a successful Project During the buildup phase, each member in…   Read more»

]]> dfc12f98a2fd6ee9e6463a3bf1e6664c https://medicaldevicecourses.com/activity/p/15028/ Wed, 15 May 2019 19:02:25 -0400 Hello, When we conduct a risk management meeting give an wide array of risk that can detail a project,identifying key risks and developing plans for preventing then or mitigating their adverse effects.Risk management consists of three steps: 1. conducting a…   Read more»

]]> a1021a584d9e3faee86ba69d318e7129 https://medicaldevicecourses.com/activity/p/14942/ Wed, 15 May 2019 19:01:36 -0400 Risk management planning is important process how you do risk identification, risk analysis, risk responses, risk monitoring and control. Risk is not always bad, when we think about risk we always think about the negative impact of risk .But we…   Read more»

]]> e0d90fca42fa7b93d8bae489800db1e4 https://medicaldevicecourses.com/activity/p/14919/ Wed, 15 May 2019 19:01:22 -0400 Hello everyone, I agree with the importance of choosing a project team. Sometimes there are situation in which we have to choose a person due to internal pressure. It can be from your manager or upper manager. As it was…   Read more»

]]> e622665c00bbf04aa357bb32bf597940 https://medicaldevicecourses.com/activity/p/14918/ Wed, 15 May 2019 19:01:21 -0400 Currently, I work for New York Presbyterian in New York area. It is a really good place to work for. The organization i experience a Matrix organization.I have my Bio-med team or my Department that i do my daily work….   Read more»

]]> e0e3ff14544e6424f0231003150f3c81 https://medicaldevicecourses.com/activity/p/14803/ Wed, 15 May 2019 19:00:13 -0400 Hello, For any case that require a material change, even if it is already in market. It has to be notified to the FDA. It is clearly mentioned in the FDA guidance document . A change or modification in the…   Read more»

]]> aee8a63bd3baef3a398e488e7ea22436 https://medicaldevicecourses.com/activity/p/14802/ Wed, 15 May 2019 19:00:12 -0400 Hello all, A project proposal is the core document that help you to sell a potential project to sponsors and stakeholder. A project proposal is unique to each project, of course, but the format is basically the same. The best…   Read more»

]]> e3ff416eedcd981a8354a254c313a9a8 https://medicaldevicecourses.com/activity/p/14790/ Wed, 15 May 2019 19:00:05 -0400 Hello, Pros and cons of the 3 Organization structure is very well explained in this week lecture. I worked with Functional type organisation for 2 years. What don’t like in the functional organization is that it form silo in culture…   Read more»

]]> 192dec4a8dec329839ca6146fe605461 https://medicaldevicecourses.com/activity/p/14766/ Wed, 15 May 2019 18:59:52 -0400 I agree with the discussion above mentioned by srg36 and Parth D.Patel. Clinical trial are very expensive. we need clinical trial for a new innovation or a new design. For the device that are already existing in the market will…   Read more»

]]> 68bebc0b848e0a2f012fbd1c1cca904d https://medicaldevicecourses.com/activity/p/14765/ Wed, 15 May 2019 18:59:52 -0400 Hello everyone , For the last one year i was working as a quality control analyst at Impax laboratory. I was in charge of new drug development. Protocol testing , R&D testing. I was able to work on oxycodone drug…   Read more»

]]> c0f5dfdb456d41852e71565230d8990c https://medicaldevicecourses.com/activity/p/14764/ Wed, 15 May 2019 18:59:51 -0400 Hello everyone, I agree with most of the discussion above . One of the most important a basic requirement of a project manager is communication skill. He/she should be a team leader. Most of there time is spend on communication….   Read more»

]]> ad0c034fc62e2f405fbe5e7c96153d38 https://medicaldevicecourses.com/activity/p/11394/ Wed, 15 May 2019 16:44:33 -0400 Hi, I do agree with the above discussions. written agreements have advantages over oral agreement Benefits of written agreement 1.provide proof of what was agreed between you and the hirer. 2. help to prevent misunderstandings or disputes by making the…   Read more»

]]> 01788fd0d3f51bf4679f2357fb342732 https://medicaldevicecourses.com/activity/p/11376/ Wed, 15 May 2019 16:44:22 -0400 Hi, A very interesting topic. I agree with the benefit mentioned above for the out-of-court dispute resolution. Why we are settle out of court 1.An independent, neutral third person (a “neutral”) listens to the facts from all sides and tries…   Read more»

]]> 3d32435dffa399533e3200b3dc512b52 https://medicaldevicecourses.com/activity/p/11341/ Wed, 15 May 2019 16:44:03 -0400 Hi, Thank you for sharing the link. Very interesting topic Hetal. The Federal Anti-Kickback Statute and the Stark Law are often confused because both laws deal with remuneration related to improper referrals.The Anti-Kickback Statute is a criminal law that applies…   Read more»

]]> 1033c544bf4ec1eff111c63c33edb994 https://medicaldevicecourses.com/activity/p/11325/ Wed, 15 May 2019 16:43:56 -0400 Through-out this course syllabus Dr.simon has showed us how a real medial device industry works. I had a real good learning experience . I also look forward for more of the other courses. With this project, now i have a…   Read more»

]]> 8c729ad106075ee95594f548c8ca0f98 https://medicaldevicecourses.com/activity/p/11249/ Wed, 15 May 2019 16:43:19 -0400 Hi, Organizational Behavior (OB) is the study and application of knowledge about how people, individuals, and groups act in organizations. It does this by taking a system approach. That is, it interprets people-organization relationships in terms of the whole person,…   Read more»

]]> 65475ac921925419ad6ae88422f96d34 https://medicaldevicecourses.com/activity/p/11225/ Wed, 15 May 2019 16:43:05 -0400 Hi, If i start my own company i will go with matrix structure that allows team members to share information more readily across task boundaries; it also allows for specialization that can increase depth of knowledge. I would like to…   Read more»

]]> c84025341ee6c9cb4e7e50883a5d0956 https://medicaldevicecourses.com/activity/p/11214/ Wed, 15 May 2019 16:43:00 -0400 Hi, To be successful, project teams must work together to an accomplish a goal, and usually that goal is finishing the project on time and within budget. But, there is more to selecting a team than simply choosing a bunch…   Read more»

]]> fcc6c1faa1e81bf69bfe03fc2f75cdb4 https://medicaldevicecourses.com/activity/p/11208/ Wed, 15 May 2019 16:42:57 -0400 Hi, A organization structure defines a reporting relationship in company.I currently work in a functional organization. Once we get a project, we work as a team and submit the project on time .We do not have any communication with other…   Read more»

]]> 9efac4d434f222bb6442940ebf6124ec https://medicaldevicecourses.com/activity/p/11121/ Wed, 15 May 2019 16:40:05 -0400 Hi, I do agree with the above discussion, Risk severity is categorized into three levels and includes a duration component. The three levels are medical device-related deaths or serious injuries, medical device-related non-serious adverse events, and medical device-related events without…   Read more»

]]> 15d2e49bb42b48ae7db864fcf960e1a3 https://medicaldevicecourses.com/activity/p/11114/ Wed, 15 May 2019 16:40:01 -0400 Hi, I did some research and in my opinion the best way to address risks is pseudo-quantitative method is probably the risk matrix, which classifies the likelihood of a risk in one category and the consequences in another category. The…   Read more»

]]> 2d18586a72f09738ac4879b563a0b695 https://medicaldevicecourses.com/activity/p/11071/ Wed, 15 May 2019 16:39:38 -0400 Hi, I do agree with the above issue in risk management.Risk assessment includes the estimation and evaluation of a risk. FDA’s premarketing risk assessment is intended to identify and quantify risks detected during clinical development and to evaluate how carefully…   Read more»

]]> 4192f1bfe3446f75b7ecffcea4c56460 https://medicaldevicecourses.com/activity/p/10993/ Wed, 15 May 2019 16:38:38 -0400 Hi, To complete a project successfully, you must control a large number of activities ,and ensure that they are completed on schedule. If you miss a deadline or finish a task out of sequence, there could be a knock-on effect…   Read more»

]]> a75e4e365abaa2a612a6878688e871bd https://medicaldevicecourses.com/activity/p/10941/ Wed, 15 May 2019 16:38:09 -0400 Hi, A design review is a milestone within the product development process whereby a design is evaluated against its requirements in order to verify the outcomes of the previous activity and identify the issue and correct it . There are…   Read more»

]]> 87083f4bbc8ce2bbc6241d44059444fd https://medicaldevicecourses.com/activity/p/10931/ Wed, 15 May 2019 16:38:03 -0400 Hi, I agree with the above discussion, following are the problem during design transfer. 1. The workflow of the manufacturing organization is disrupted by having to wait for released materials, procedures, and test fixtures. 2.The purchasing department does not have…   Read more»

]]> af2890d353bcf235e68ce21a2b7b0019 https://medicaldevicecourses.com/activity/p/10816/ Wed, 15 May 2019 16:36:50 -0400 Hi, Design control are interrelated set of practices and procedures that are incorporated into the design and development process.A design control provides a systematic assessment of the design an integral part of development. As a result ,deficiencies in design input…   Read more»

]]> e869081eabebb76e83e8c7f5e94f4625 https://medicaldevicecourses.com/activity/p/10809/ Wed, 15 May 2019 16:36:47 -0400 Hi, I agree with the above discussion . Design control is required for the EU release product .Actually DHF is used only before product release .Once the product is commercially released ,all changes are under production control and all changes…   Read more»

]]> 4c8199197bbdc5c763497fb1cfe37565 https://medicaldevicecourses.com/activity/p/10720/ Wed, 15 May 2019 16:35:53 -0400 The old saying is true: It’s not technology or financial assets that make your business great—it’s your people. You’ll have a critical advantage over your competition if you know how to retain good people. Retention doesn’t mean you try to…   Read more»

]]>