https://medicaldevicecourses.com/members/quanzi/activity/ Activity feed for quanzi. Sat, 16 May 2026 03:45:18 -0400 https://buddypress.org/?v= en-US 30 hourly 2 059f80a576c9dfccf42a7614c6686c94 https://medicaldevicecourses.com/activity/p/20149/ Tue, 18 Aug 2020 15:25:38 -0400 I would prefer to work for a matrix style organization. Each organizational structure has its downsides; however, I believe the matrix style organization structure allows for the best use of resources and allows for greater collaboration amongst different departments. Information…   Read more»

]]> 43f3b7b79ba03c5680905e3c1035f34f https://medicaldevicecourses.com/activity/p/20148/ Tue, 18 Aug 2020 14:58:17 -0400 Trade secrets are typically for items that cannot be patented. In the case of the Coca-Cola example, the recipe cannot be patented because it is created using ingredients that are not novel in nature. There is no engineered technology that…   Read more»

]]> 800c7e90d2d2f6da84a944425ca746d1 https://medicaldevicecourses.com/activity/p/20147/ Tue, 18 Aug 2020 14:39:46 -0400 Upper management is strategic and middle management is tactical, according to the lecture. What exact traits would be required for each level of management? Upper management is responsible for the operations of the entire company.It is important to be assertive…   Read more»

]]> cc58a56d3084fe23c12bdeae89a9addb https://medicaldevicecourses.com/activity/p/20138/ Thu, 13 Aug 2020 08:25:29 -0400 A risk management file is the culmination of all documents related to the risk management process. It is a living document, and includes a risk management plan, risk analysis, risk evaluation, risk controls, the evaluation of overall risk acceptability, risk…   Read more»

]]> 2c9b6531d45ff00f79e58293f9286dc0 https://medicaldevicecourses.com/activity/p/20137/ Thu, 13 Aug 2020 08:04:02 -0400 Risk control is the process of identifying a risk and implementing changes that reduce the risk in order to protect the user of the product. The three types of risk management are product design, protective measures incorporated into the medical…   Read more»

]]> 82eb88a40b8986d4f22022b1a5266da1 https://medicaldevicecourses.com/activity/p/20136/ Thu, 13 Aug 2020 07:36:37 -0400 The ISO regulation that governs risk management is ISO 14971. A medical device company is required to perform a risk assessment. This includes performing risk analysis to identify hazards and their level of risk. Then a risk estimation must be…   Read more»

]]> c4dfe498ce3a4e6f0fc57a97138f2998 https://medicaldevicecourses.com/activity/p/20134/ Fri, 07 Aug 2020 18:41:38 -0400 Design controls are a set of quality practices and procedures required by the FDA during the design process. They are established per 21 CFR 820.30.  These processes are in place to make sure user needs are met, the product functions…   Read more»

]]> 647b99d8f01eddfd9bb87cbeb185dbb3 https://medicaldevicecourses.com/activity/p/20133/ Fri, 07 Aug 2020 18:13:04 -0400 One issue that can arise from the design control process is the improper assessment of the risks associated with the product. If the potential risks of a product are underestimated, certain tests may be overlooked, leading to a potentially defective…   Read more»

]]> cbc34844fa0cb9b5d273bfb00a2d37e2 https://medicaldevicecourses.com/activity/p/20127/ Thu, 06 Aug 2020 05:04:37 -0400 Although a DHF is not required in the EU, design controls are still necessary. There are documents that are necessary when designing medical devices in the EU. These include the technical file, the declaration of conformity, the design dossier, and…   Read more»

]]> 688d48e60a8c05420026262dcbb728aa https://medicaldevicecourses.com/activity/p/20114/ Sat, 01 Aug 2020 06:41:53 -0400 What is a multi center clinical trials and what are some difficulties faced with this trial design? What can be done to reduce these issues? A multi center clinical trial is a single clinical trial carried out at multiple facilities….   Read more»

]]> 1585efaf065dfaeb8cf8ad01e1d814e6 https://medicaldevicecourses.com/activity/p/20113/ Sat, 01 Aug 2020 06:41:00 -0400 When performing clinical trials you will often see the design of these trials will be randomized and blind. But what do these terms mean? A randomized trial refers to how the control or the test medication or device is being…   Read more»

]]> 41e3fcc506d02c51ab58eadd542ab135 https://medicaldevicecourses.com/activity/p/20112/ Sat, 01 Aug 2020 06:39:37 -0400 I believe that it is important to have a clinical background when working on clinical research, Although this does depend on the capacity in which you are working with patients. This is because you are dealing with patients from drawing…   Read more»

]]> 779ba902c80083504e6ffaa9f17116df https://medicaldevicecourses.com/activity/p/20109/ Thu, 23 Jul 2020 06:07:00 -0400 An LLC is a business structure that offers limited liability protection. It has a flow-through taxation process. LLC’s can choose to be taxed as a partnership or as a corporation. An LLC has a flexible management structure and can be…   Read more»

]]> c8fa65a340c59e26469be9c6683952bb https://medicaldevicecourses.com/activity/p/20108/ Thu, 23 Jul 2020 05:21:55 -0400 Emotional intelligence refers to the ability to be aware of, understand, and communicate one’s own emotions, as well as the ability to empathize with others and communicate effectively in interpersonal relationships. Emotional intelligence is considered an interpersonal skill that is…   Read more»

]]> 62af89b79aa599c5e4e33451cf4ea0ce https://medicaldevicecourses.com/activity/p/20107/ Thu, 23 Jul 2020 04:38:34 -0400 With the plethora of social media platforms and short attention spans, it has become an art to grab attention before the viewer scrolls down their timeline. Many social media “influencers” have mastered grabbing attention via comedic videos. Many companies use…   Read more»

]]> 2508fe95ed95b3994cf27d1ea7cb52d9 https://medicaldevicecourses.com/activity/p/20103/ Sat, 18 Jul 2020 20:25:18 -0400 Once the physician has an idea, they must determine which class their device falls into. The next concern would be the presentation of the idea to the FDA. They would need to submit an Investigational device exemption if the device…   Read more»

]]> e5ef1461b42539ffc4bce00f00aff058 https://medicaldevicecourses.com/activity/p/20102/ Sat, 18 Jul 2020 20:22:19 -0400 Quality assurance is all of the processes established to ensure that a company is producing the best product to their customers. This process protects the safety of consumers that use the product. Quality control is the action of inspecting products…   Read more»

]]> 1c849729eda86a94fdb783ea4b382678 https://medicaldevicecourses.com/activity/p/20101/ Sat, 18 Jul 2020 20:21:40 -0400 I believe it is important to protect your investments. It takes time and money to build a company. When dealing with medical devices, it can be an even longer process, due to the scientific process behind many of these devices….   Read more»

]]> 7719d82fa5b7123f1cc686800a1e7234 https://medicaldevicecourses.com/activity/p/20097/ Thu, 16 Jul 2020 15:07:06 -0400 I am referring to the material having the desired interface with the tissue. Breast tissue is soft and fluid. A biomaterial acting  as an implant must be fluid in nature as well, to match the interface of the breast tissue. 

]]> b0a3bfc2af6b70a0f15039d2c2e0c209 https://medicaldevicecourses.com/activity/p/20084/ Fri, 10 Jul 2020 06:36:29 -0400 In order to test this new bio-material, I would perform testing based on the ISO 10993 international standard. This standard has 18 parts that evaluate how a device will be used and which tests to perform. It includes how the…   Read more»

]]> 84bb2afe124c8b5eca2467f981c65ba1 https://medicaldevicecourses.com/activity/p/20083/ Fri, 10 Jul 2020 06:19:27 -0400 It is important to be precise when selecting biomaterials for a device. They behave differently and have different interactions in the body. Some are necessary for a rigid role while others are meant to have some fluidity in certain areas…   Read more»

]]> 9dff5340ca63725cfd9dedb60d021f80 https://medicaldevicecourses.com/activity/p/20082/ Fri, 10 Jul 2020 05:47:50 -0400 The issues that can present in this situation can arise from the vast distance between the contracting company and the outsourcing company. The main issue can be lack of communication, which can lead to misunderstandings. It is difficult to check…   Read more»

]]> c46f9d9b9c48933ec29acc3b59da4345 https://medicaldevicecourses.com/activity/p/20081/ Mon, 06 Jul 2020 03:23:42 -0400 I believe the main challenge for project management for medical devices is that there are more strict regulations with the FDA. If a project is not approved, it can set the schedule for compilation of a project back significantly, as…   Read more»

]]> 6a5f35937fdb193db79f4b96806b53a0 https://medicaldevicecourses.com/activity/p/20080/ Mon, 06 Jul 2020 03:15:38 -0400 For an argument in favor of academia, I would highlight that this job would be ideal if your career goal is to conduct research. Academia requires significant research and discovery, and those in academia, particularly professors, spend a significant amount…   Read more»

]]> 38954922b0911b93c469295e7c78d600 https://medicaldevicecourses.com/activity/p/20079/ Mon, 06 Jul 2020 03:03:21 -0400 COVID-19 has affected every area of life. The medical device development industry is no exception. Some changes have been delays to clinical trials and disrupted regulatory processes. Due to the need for certain devices, others have taken less priority ….   Read more»

]]> 7c8e10671f02f5e97e3fd5c4e55e303f https://medicaldevicecourses.com/activity/p/20076/ Fri, 03 Jul 2020 15:57:36 -0400 0