https://medicaldevicecourses.com/members/sybleb/activity/ Activity feed for sb2363. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 8c5d9e1bc2ad0f252cc7740d541758c9 https://medicaldevicecourses.com/activity/p/19201/ Wed, 27 Nov 2019 20:08:28 -0500 An NDA protects non-public information. The factors to consider while executing a Non-Disclosure Agreement may vary from a project-to-project. The main factors being ‘What information is considered confidential’ here the definition of confidential information should describe the type of information…   Read more»

]]> 65480e05e03e00e2da8fa5aa4e6e980b https://medicaldevicecourses.com/activity/p/19199/ Wed, 27 Nov 2019 19:47:18 -0500 In my opinion it is fair enough and not too restrictive because the law is enforced only after there have been cases where the physician was easily bribed to sell their product and make a huge profit. The physician will…   Read more»

]]> 968dece9d555f267b3d81772ce812134 https://medicaldevicecourses.com/activity/p/19198/ Wed, 27 Nov 2019 19:25:07 -0500 A written contract obviously has an advantage over a verbal contract. The terms Verbal and Oral contract can be used interchangeably and mean the same. A verbal contract is a contract that in which the terms of terms and the…   Read more»

]]> 2ef59a63f08b0610471106d00175cb2c https://medicaldevicecourses.com/activity/p/19134/ Wed, 20 Nov 2019 04:17:03 -0500 I believe I would like to work in a matrix based organization as it gets the team members and managers to work on a specific goal. There is quick flow of information throughout the project which results in an increase…   Read more»

]]> 2558111f17d4f2becb62e654550b1199 https://medicaldevicecourses.com/activity/p/19133/ Wed, 20 Nov 2019 04:02:51 -0500 We had our first in-person meeting the very next week Friday our project team was formed. We have decided to meed every Friday evening to check our progress on the project and help each other by having inputs from everyone…   Read more»

]]> 94fafb9f87a090af052876786ec62e53 https://medicaldevicecourses.com/activity/p/19132/ Wed, 20 Nov 2019 03:45:57 -0500 When given a choice to be able to choose a project team, which mostly happens in a matrix organization the project manager would like to choose a subject matter expert from the departments needed for that particular project to form…   Read more»

]]> 64b5b400c34cdfad172dfeff8142b1cb https://medicaldevicecourses.com/activity/p/19110/ Mon, 18 Nov 2019 01:28:09 -0500 I would choose acceptance for low severity of risk as this is a good strategy to use for very small risks that won’t have much of an impact on your project if they happen and could be easily dealt with…   Read more»

]]> ebf49214498faacb89de8bf90510df08 https://medicaldevicecourses.com/activity/p/19106/ Mon, 18 Nov 2019 01:08:47 -0500 In the medical device industry risks are identified by the residual safety risk zone for each risk identified to determine it’s acceptability. They may be identified into 3 zones. Zone 1 is when the risk are usually acceptable and do…   Read more»

]]> b9b45bd10c12b250a8e7ecdc5dcf36d9 https://medicaldevicecourses.com/activity/p/19103/ Mon, 18 Nov 2019 00:49:50 -0500 In my opinion risk management meetings are successful when there is a full participation from all the members of the team. Brainstorming becomes easier and inputs from all the members helps consider the different risks which one might have not…   Read more»

]]> 0a437621ba42c3d233a093f8daf6068c https://medicaldevicecourses.com/activity/p/19009/ Mon, 04 Nov 2019 21:43:13 -0500 Deign Control problems seem obvious only after adverse events, before that they are not so evident. Not starting out with a set of product requirements and do a top-down design the way the FDA expects is another factor that causes…   Read more»

]]> 381a0b021a78af8e0c4d770b94459c80 https://medicaldevicecourses.com/activity/p/19008/ Mon, 04 Nov 2019 21:15:42 -0500 In my opinion it will be beneficial if a particular pattern is followed while making a Gantt chart. Having the dates displayed right at the top for individual tasks apart for the entire project start/end date, while having the tasks…   Read more»

]]> 3d804bb4cd88779ae559fb8b3416486f https://medicaldevicecourses.com/activity/p/19007/ Mon, 04 Nov 2019 20:59:30 -0500 Verification and Validation are two different processes where validation follows verification. Verification is where you test/verify that the design outputs match your design inputs. It can include tests, analyses and inspections. Verification is typically making sure that you have objective…   Read more»

]]> 130247664d2310e2c3707d325d8895a1 https://medicaldevicecourses.com/activity/p/18978/ Sat, 02 Nov 2019 18:18:40 -0400 Design Controls are a part of 21 CFR part 820.30 which are presently adopted into the ISO 13485:2016 standard to ensure that the device or the even a component that you are making follows the design control process as it…   Read more»

]]> 304bc544968bcbd4f8d3b321833b8e7c https://medicaldevicecourses.com/activity/p/18977/ Sat, 02 Nov 2019 17:38:34 -0400 I guess the sources of design input will depend on a number factors such as the customer requirements who can be doctors or patients, safety, similar designs from previously manufactured devices and their designs, market research and so on. After…   Read more»

]]> d052ac31e9ffd651c37c7f0b86398342 https://medicaldevicecourses.com/activity/p/18976/ Sat, 02 Nov 2019 17:06:07 -0400 Minutes of a meeting are essential. They contain the important points discussed in the meeting. It contains the necessary action items and the assignee for the action item which one would tend to forget after the meeting has ended, but…   Read more»

]]> 314313af38b7079bb63b845713e0738c https://medicaldevicecourses.com/activity/p/18908/ Thu, 24 Oct 2019 01:16:48 -0400 I would like to work as a Clinical Quality Assurance Auditor (CQA) who is responsible to ensure that the trials are performed as per the guidelines and regulations considering the various GxP practices such as Good Clinical Practices (GCP), Good…   Read more»

]]> 3f24e5cb059f15aeadfc05d31468673f https://medicaldevicecourses.com/activity/p/18907/ Thu, 24 Oct 2019 01:01:04 -0400 Clinical trials are meant to find new ways to detect, prevent, treat diseases or make an improvement to an existing drug or device. New methods/procedures are not possible without clinical trials.                   …   Read more»

]]> 6b6b25ee1dcc7cdfa2df0b5542276d4c https://medicaldevicecourses.com/activity/p/18901/ Wed, 23 Oct 2019 21:56:25 -0400 I feel that a placebo-controlled study is important and valid. The purpose of the study as we know is to understand the effect of  treatment that do not depend on the treatment itself. The control group and the group of…   Read more»

]]> 544ea3db3a691877291ae86bacf96ea4 https://medicaldevicecourses.com/activity/p/18840/ Sat, 19 Oct 2019 14:50:56 -0400 Color is very important in branding and marketing because it is where the first impression of the customer lies. Colors convey emotions, experiences and feelings more than being just a visual aid. Colors and shapes are an immediate way of…   Read more»

]]> 791a445a807cde7e7743becfbc57cfef https://medicaldevicecourses.com/activity/p/18839/ Sat, 19 Oct 2019 14:31:20 -0400 The most memorable advertisement I remember was around 10 years back of Tide detergent on Indian television channels where a man walks using high sticks to walk on the road wearing a white shirt to avoid dirty water splashed by…   Read more»

]]> 9d1ebc26d7d3cd131fca0a21f0016a57 https://medicaldevicecourses.com/activity/p/18838/ Sat, 19 Oct 2019 13:59:18 -0400 Marketing to me is that the companies/firms should assess the needs of the customers most importantly and depending on those needs make appropriate decisions after a proper research of the already existing products to understand how they will be able…   Read more»

]]> e73c0de49b8fe420e28a6e23c3eecae6 https://medicaldevicecourses.com/activity/p/18768/ Wed, 09 Oct 2019 22:22:49 -0400 The type of corporation formed will depend on various factors, a few of which could be the number of people willing to start the business, how they are owned, how they pay taxes, the amount of risk involved to personal…   Read more»

]]> a7a237f7f0b1fa29ac374ad53fb3f241 https://medicaldevicecourses.com/activity/p/18767/ Wed, 09 Oct 2019 22:21:58 -0400 I would prefer to start initially as a Sole Proprietorship as this would be more flexible and would allow me to take the decisions for my business as per my vision and goals for the company, provided I have the…   Read more»

]]> 4369be4e2f7ab329e1e5805702969d89 https://medicaldevicecourses.com/activity/p/18766/ Wed, 09 Oct 2019 22:20:32 -0400 As seen from the lectures for this week we know that S-corp follow the flow through taxes while C-corp has the double taxation. However, the C-corp has its own set of advantages. The shares can be publicly traded and the…   Read more»

]]> adcc455ef66a18777a64b31df18c6f8b https://medicaldevicecourses.com/activity/p/18725/ Sun, 06 Oct 2019 15:38:10 -0400 A good relationship between the Quality and other departments can be maintained with an understanding by other departments that it is important for the product to comply with the standards set by the organizations rather than being rejected and having…   Read more»

]]> 454979dc749912696b2ed1d426930dbc https://medicaldevicecourses.com/activity/p/18724/ Sun, 06 Oct 2019 15:23:30 -0400 The Quality Control of an organization can be improved by making sure that there is a good communication within the the quality control department and between the quality control department and other departments. A good quality management system (QMS) is…   Read more»

]]> 58d50a91bf39cb950137864bab79fa07 https://medicaldevicecourses.com/activity/p/18723/ Sun, 06 Oct 2019 15:06:46 -0400 The quality department is the department responsible for making sure that the other departments in the company are in compliance with the standards which can be that of the company, FDA, ISO standards etc. If the department does not adhere…   Read more»

]]> c97ff645b8c3a8587e47647172a59a3b https://medicaldevicecourses.com/activity/p/18648/ Sat, 28 Sep 2019 00:06:30 -0400 I believe the FDA is doing the right thing and is not being strict at all as it is there to assure that we ,the public, is safe  and there is safety and efficacy in all the products it regulates….   Read more»

]]> e3479ae1c168beb564eeef099536f03f https://medicaldevicecourses.com/activity/p/18647/ Fri, 27 Sep 2019 23:56:15 -0400 First and foremost the physician would have a lot of trouble in financing the project. Apart from this the time taken to complete the project could be vast. Knowledge of design controls would be highly essential as mentioned, so that…   Read more»

]]> 334a5c19a3f1c9a02ba20ee9653f3453 https://medicaldevicecourses.com/activity/p/18646/ Fri, 27 Sep 2019 23:40:13 -0400 The de Novo pathway was introduced to address novel devices without a predicate device, for low to moderate risk devices. After the submission of the de Novo the FDA reviews the device and adjusts it in the required classification of…   Read more»

]]> 0e04c2e6b27c96b8981ff607b7533268 https://medicaldevicecourses.com/activity/p/18608/ Sun, 22 Sep 2019 10:47:27 -0400 I personally would like to do research in the industry, that is where the results will be utilized right away. Research in the industry is more result oriented and would result in an end product while in academia research is…   Read more»

]]> 8ceb07b3d051fbb0a96e5f9d3cac8f23 https://medicaldevicecourses.com/activity/p/18607/ Sun, 22 Sep 2019 10:22:10 -0400 First of all the biocompatibility testing should be carried out as per the ISO 10993 standards prior to  clinical studies of the device or the material. The ISO 10993 has parts from 1 through 18 has the various regulations listed…   Read more»

]]> 4eda20869985179b70b83c0694a4fe12 https://medicaldevicecourses.com/activity/p/18606/ Sun, 22 Sep 2019 10:03:10 -0400 Assuming that the design will not have any flaws and will give no problems is one of the biggest mistake. This is because any design or study will have some pitfalls associated with it. There may be delays in the…   Read more»

]]> 371326a285213a5874ab4af696ac5b67 https://medicaldevicecourses.com/activity/p/18544/ Sun, 15 Sep 2019 21:05:53 -0400 In my opinion the most critical project objective should be whether the project is achievable and understandable, these both will go hand in hand. The project is achievable if it’s objective is understood well. The initiation phase would decide if…   Read more»

]]> 97f0be3a732f088ae6520ccde498c237 https://medicaldevicecourses.com/activity/p/18537/ Sun, 15 Sep 2019 11:21:06 -0400 In my opinion, missing a milestone shows a lack in the planning phase. This is because the planning phase should consider the time that would be needed in performing the trials/tests and in case of failure of these trials/tests the…   Read more»

]]> 7a4e86ba51c20b0c5c73897c40f76c21 https://medicaldevicecourses.com/activity/p/18536/ Sun, 15 Sep 2019 11:10:01 -0400 I think the planning phase is the most crucial phase in the project management life cycle since the other phases are dependent on the planning phase. It is the phase where the project team is formed which marks how successfully…   Read more»

]]> b9c890a50565a18127a733b7edfda29d https://medicaldevicecourses.com/activity/p/18474/ Sun, 08 Sep 2019 09:14:21 -0400 I agree with most of the replies that having a job after having completed your BS is a good idea. Once you have worked for a year or two you are most likely to know whether you want to work…   Read more»

]]> 43ecb0d748a7864d63118a8045253a81 https://medicaldevicecourses.com/activity/p/18473/ Sun, 08 Sep 2019 08:56:46 -0400 In my opinion the ratio of informational and practical courses should be 50:50 at a graduate level since the theoretical knowledge has been majorly covered in the undergraduate courses and master’s being at an advanced level should help us learn…   Read more»

]]> 5e45ee98506cda37b2b77e1941ec7e2b https://medicaldevicecourses.com/activity/p/18472/ Sun, 08 Sep 2019 08:42:10 -0400 The merits of Industry and Academia vary depending on various factors. Although I do not have any industry experience but the merits of Industry as seen from the lecture and as heard from people already into the industry is that…   Read more»

]]> 4eb090ce07feeecd82a20757b74a6f0c https://medicaldevicecourses.com/activity/p/18304/ Wed, 15 May 2019 21:47:08 -0400 I would choose to be an engineer to start with for a good amount of years. This will let me work as an engineer where I can apply all my skills and knowledge that I have gained from my undergrad…   Read more»

]]> bbfba5834c607b556a561ae7de9aec82 https://medicaldevicecourses.com/activity/p/18303/ Wed, 15 May 2019 21:47:07 -0400 I would like to choose the role of being a Clinical Research Associate (CRA) as they are one of the important people of the team that get most of the work done which involves writing a protocol, having the IRB…   Read more»

]]> 6b9d799b5c076844bbdefbaf9d5e3d4e https://medicaldevicecourses.com/activity/p/18302/ Wed, 15 May 2019 21:47:07 -0400 According to me in order to build a good relationship with your vendor the key thing is a good level of communication between the two so that they are well informed and up-to-date on the things going on. Have your…   Read more»

]]> ef8ede8e208fcc30fd34a1911ad94f9d https://medicaldevicecourses.com/activity/p/18249/ Wed, 15 May 2019 21:46:40 -0400 As a Project Manager in a medical device industry I would learn to identify what are the different ways to that motivates an individual. Try to reward and provide recognition to motivate the team members on tasks that are tough…   Read more»

]]> 2b5515a98c3d5a88874bef4f12ce06ac https://medicaldevicecourses.com/activity/p/18248/ Wed, 15 May 2019 21:46:40 -0400 For me the study did not surprise much except that making a difference should have had a higher percentage. According to me the work being exciting and challenging, career growth and development, working with great people and meaningful work/ making…   Read more»

]]> 7fd403b963a8088203c119dce05debc4 https://medicaldevicecourses.com/activity/p/18247/ Wed, 15 May 2019 21:46:39 -0400 The things that motivate me are the urge to bring a new change, the want to move ahead in life, to make progress and bring in new changes that will make a lot of positive difference that would not just…   Read more»

]]> 50ea001f546ce39272d99200097f31e0 https://medicaldevicecourses.com/activity/p/18181/ Wed, 15 May 2019 21:46:04 -0400 The project manager should be the one communicating the project details within various teams. Communication being an important part of the project, I believe most of the communication within a project team should be carried out via emails and face-to-face….   Read more»

]]> b2ad43282ecae6903c7467c4cd4fa9f1 https://medicaldevicecourses.com/activity/p/18180/ Wed, 15 May 2019 21:46:04 -0400 As explained in this week’s lecture for procurement planning before choosing your vendor the team should identify the project needs which comes from having a broad understanding of the entire project and what you need, how much to get and…   Read more»

]]> ada5ff7de25e8e0f269b3adcbbaac21b https://medicaldevicecourses.com/activity/p/18178/ Wed, 15 May 2019 21:46:03 -0400 In my opinion having a common communication management plan for the company is a good choice until and unless some authority is given to make a few changes to the common communication plan depending on the needs of the project…   Read more»

]]> e7465e97aa7e4e4f1a3ae9948e0e358a https://medicaldevicecourses.com/activity/p/18134/ Wed, 15 May 2019 21:45:41 -0400 Verification is a process which checks that a device or a product satisfies all the regulations or specification requirements i.e. if the input matches the expected output. As agreed by most above verification can take place at different stages of…   Read more»

]]> fd36eb79151d9c5c5274e9dea0c565bc https://medicaldevicecourses.com/activity/p/18130/ Wed, 15 May 2019 21:45:39 -0400 I believe that depending on the situation and how negative the values of SV and CV are it would be justified to select any of the situation. However, I would choose the option 2 where the SV is negative and…   Read more»

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