https://medicaldevicecourses.com/members/aniketb/activity/ Activity feed for AniketB. Fri, 24 Apr 2026 21:58:15 -0400 https://buddypress.org/?v= en-US 30 hourly 2 c31551e8a854c4ec9286ccd90ab3a597 https://medicaldevicecourses.com/activity/p/19190/ Tue, 26 Nov 2019 05:28:40 -0500 A patent is when we do/think of something unique and has not been done yet, only then we are eligible to apply for a patent. While an NDA is something that can be applied to the thing in which you…   Read more»

]]> a9b3b498a9fdf3828b5bb16c0a77d680 https://medicaldevicecourses.com/activity/p/19189/ Tue, 26 Nov 2019 05:20:07 -0500 I think the gift restriction is a good thing as not all companies are at the same level in terms of their budget, one company has the best product but not much capital can easily fall short in pleasing the…   Read more»

]]> 56bf001686fe0112f826bd0ff3564334 https://medicaldevicecourses.com/activity/p/19188/ Tue, 26 Nov 2019 05:10:32 -0500 A written agreement is the one done on paper and signed by the people agreeing on the contract/ terms within the document. A verbal agreement is when both parties agree to certain terms verbally and that’s it.The advantage of a…   Read more»

]]> 24da73c909758be829428a76bb1f8476 https://medicaldevicecourses.com/activity/p/19150/ Fri, 22 Nov 2019 22:00:53 -0500 So, we had decided to meet on video call as its difficult to manage to come for an in-person meet every week, we have completed the DDP, DID and have come up with Pre-Clinical, clinical and regulatory first draft.So we…   Read more»

]]> 791a94c76559d0a634fa5b157dc9dd86 https://medicaldevicecourses.com/activity/p/19149/ Fri, 22 Nov 2019 21:54:07 -0500 While forming a team I don’t think getting a person who you know on a team will benefit unless the person is good at the job that he/she has to perform as in the end we want a completed project…   Read more»

]]> a1c63ffa5d90679d5722bc6f4478a5df https://medicaldevicecourses.com/activity/p/19138/ Wed, 20 Nov 2019 20:54:54 -0500 I would prefer working in a matrix organization as there is direct communication within the team and there are no silos nor is there any competition within themselves are they are assigned a simple task of completing the project on…   Read more»

]]> 7dec2caedee1efe6116954427abcc47e https://medicaldevicecourses.com/activity/p/19109/ Mon, 18 Nov 2019 01:26:41 -0500 For a low severity risk, we can accept the risk depending on its occurrence or try to mitigate the risk.While or the high severity of the risk should be either avoided but it will be a huge loss as it…   Read more»

]]> e3ce2cd45d60941d2e84e2d2505d94a4 https://medicaldevicecourses.com/activity/p/19107/ Mon, 18 Nov 2019 01:12:47 -0500 The first option is to design it out, which is ideal as the product is not in the market yet and if there are any design changes that can be done to reduce the risk then they should be adopted.The…   Read more»

]]> 169934266f6a3d5a5bc8cc8b1fc7841c https://medicaldevicecourses.com/activity/p/19104/ Mon, 18 Nov 2019 00:49:58 -0500 FMEA is ideally used for risk management as it gives an idea as to where and how the product might fail and what impact each of the failures will cause on the overall project.Also, rate each risk according to its…   Read more»

]]> 218a2c50076cfd4b1a04b667bd44f26e https://medicaldevicecourses.com/activity/p/19013/ Tue, 05 Nov 2019 23:58:38 -0500 FDA will first see that the product does not provide any risks to the person, also make sure that the standards set by the FDA are followed by the manufacturer and have a look at the Design Control Document especially…   Read more»

]]> 33770ee89f8015fcff8e28aa38f7c436 https://medicaldevicecourses.com/activity/p/19012/ Tue, 05 Nov 2019 23:41:56 -0500 Design controls are FDA guidelines that are required for making a device. Design control has a set of files under them such as the DID, DSD, DHF, etc which are essential in bringing a device in the market which is…   Read more»

]]> 5e1b6afec54f262b22d95721f49ddc8b https://medicaldevicecourses.com/activity/p/19011/ Tue, 05 Nov 2019 23:26:44 -0500 Gantt Chart gives an idea of all the tasks that are needed to complete and project or a part of a project within a particular time frame considering the working hours, sick leave, time required for procurement of material from…   Read more»

]]> 6e47a7c382f642c05e3a5d8dbd6c42ae https://medicaldevicecourses.com/activity/p/18966/ Thu, 31 Oct 2019 17:00:47 -0400 Design control is important as it sets the workflow of the product in the market if is insufficient Design Control then there will be no direction as to how the product will be built and there will be a lot…   Read more»

]]> 2d5e6602274cdad269949d14d7985896 https://medicaldevicecourses.com/activity/p/18965/ Thu, 31 Oct 2019 16:53:09 -0400 Design inputs are basically determined by the management, market research, users, Sales representative, and the research Scientist if he can make the product. The Design inputs are not specific as the DSD is responsible for the exact specifications for the…   Read more»

]]> 68d33c8c6fa99ae725335884b31e0559 https://medicaldevicecourses.com/activity/p/18964/ Thu, 31 Oct 2019 16:42:22 -0400 Meeting minutes are written documentation for the attendees and the non-attendees to know what happened in the meeting and highlight all the important changes that were discussed in the meeting, additionally, it helps to keep a track of the timeline…   Read more»

]]> 6f694298bf2d5b6cfbc0c9dded41c9ab https://medicaldevicecourses.com/activity/p/18890/ Tue, 22 Oct 2019 06:42:38 -0400 Single Blind study is the one where only the Patient is not aware as to what drug he is getting, while in Double-Blind Study both the investigator as well as the patient is not aware of the drug being the…   Read more»

]]> cc1a1313c8377326767f359a9491d4b1 https://medicaldevicecourses.com/activity/p/18889/ Tue, 22 Oct 2019 05:41:41 -0400 Update to the topic:The right to try law passed in May 2018 has only 2 patients as of June 2019 being accepted for experimental therapy.Even I see no negative issues with the law and ideally, more people should have made…   Read more»

]]> 4ed7e1ab30e351d2c55492c298beedc6 https://medicaldevicecourses.com/activity/p/18888/ Tue, 22 Oct 2019 03:55:06 -0400 Placebo-controlled trials are the trials where we place a dummy device on a group of patients randomly selected individuals.I feel it is ethical and is necessary for studies as mentioned by Dr.Simon in his video that the information provided to…   Read more»

]]> c4bfdbade0ee1f8c6e354b751efd691a https://medicaldevicecourses.com/activity/p/18832/ Fri, 18 Oct 2019 14:35:10 -0400 I have seen a lot of food joints using red and white, while the red color as mentioned above invokes hunger, the white color represents innocence, a purity so lots of food companies do use it.On the other hand, lots…   Read more»

]]> 9fccb65aff14d15670cdf4dacbfa6ee0 https://medicaldevicecourses.com/activity/p/18831/ Fri, 18 Oct 2019 14:16:24 -0400 Emotional intelligence is to be aware of the person’s emotions and handle the situation accordingly.I support the article but it should also be considered that both sides are trying the best for themselves, the sales rep trying to get a…   Read more»

]]> 83ef557fe69f6b9a4e97006010dd678f https://medicaldevicecourses.com/activity/p/18830/ Fri, 18 Oct 2019 13:56:01 -0400 Marketing is all about selling the product to the customer in need, there are a lot of aspects to consider here, and its just not about being smart and selling the device, the sales rep does prior research of the…   Read more»

]]> 27740b4c0d71b8ca85e36342ef96a740 https://medicaldevicecourses.com/activity/p/18765/ Tue, 08 Oct 2019 09:04:53 -0400 I have worked in and LLP company where there were three partners who worked for the same company before starting their own company.I would say, a partnership is a lot of risks, money wise as well as the relationship between…   Read more»

]]> b15e78d904bf8805bfbe0eb865bd2af5 https://medicaldevicecourses.com/activity/p/18764/ Tue, 08 Oct 2019 08:49:43 -0400 In S-corp the profit is divided depending on the number of shares and the tax is deducted from your account while in C-corp the tax is deducted twice, once through the companies overall profit and again from the personal account…   Read more»

]]> dc8739edf09a349ff67c9caf754aa78e https://medicaldevicecourses.com/activity/p/18763/ Tue, 08 Oct 2019 08:36:16 -0400 The answer would defer depending on the number of people interested to form a company. If there is just one person then a sole proprietorship is the best suited for him. If there is a group of 2-3 individuals forming…   Read more»

]]> 670d99b8d75b3185a2e2a9dfe775f4e4 https://medicaldevicecourses.com/activity/p/18731/ Sun, 06 Oct 2019 20:16:47 -0400 The Quality Department oversees if the standards laid down are been followed or not as there would be a lot of loss of time, money and effort if that happens and the project would be delayed even further.Companies have a…   Read more»

]]> 0d53f4656ad8979967b4a6f65f0dc14f https://medicaldevicecourses.com/activity/p/18729/ Sun, 06 Oct 2019 20:00:33 -0400 Quality Assurance sets the standards that are required by the particular product and Quality control execute those, so both of them go hand in hand.As mentioned before QA is more of a preventive role while QC is more of a…   Read more»

]]> a409d594b980c3d8b0e4973bf4104d0b https://medicaldevicecourses.com/activity/p/18728/ Sun, 06 Oct 2019 19:39:31 -0400 There should be clear communication among the departments and all the departments should follow the SOP stated by the Quality team.A Good Quality team has set SOP’s and each of the departments within the company will adhere to the stated…   Read more»

]]> d502f290d5c134d5e21fe08c6a6f5894 https://medicaldevicecourses.com/activity/p/18659/ Sun, 29 Sep 2019 05:15:13 -0400 There is a delay in recall as there are some unforeseen issues that arise after the product is in the market for some time, though enough clinical trials are performed before the device is brought in the market, the products…   Read more»

]]> d6303d5f59838b0e7d45f4bc8b825128 https://medicaldevicecourses.com/activity/p/18658/ Sun, 29 Sep 2019 04:43:07 -0400 I was not aware of it until I came across this :In the United States, there are four different levels or categories for organic labeling.1)‘100%’ Organic: This means that all ingredients are produced organically.2)‘Organic’: At least 95% or more of…   Read more»

]]> fc424e79d0a8dc5d1ef43d9196c21bb7 https://medicaldevicecourses.com/activity/p/18657/ Sun, 29 Sep 2019 04:17:12 -0400 Yes, In my experience as a Sales and Service engineer I have met a few Doctor’s who build their own device out of curiosity as well as to earn a little extra from the sales.The challenges that the doctors face…   Read more»

]]> ddf6ae1fd0fc84c7c165621228e10db2 https://medicaldevicecourses.com/activity/p/18601/ Sat, 21 Sep 2019 20:46:38 -0400 There is some research that is limited to the time they are performed and there need to be a few other discoveries to be done before that research can be conducted further.As a researcher, one needs to keep performing experiments…   Read more»

]]> 2c67a3694537a00b4138da631468e964 https://medicaldevicecourses.com/activity/p/18600/ Sat, 21 Sep 2019 20:04:56 -0400 I feel research on animals is ethical as it’s for science, and only this way any kind of breakthrough can occur in the medical industry.If Pre-Clinical trial is necessary then we need to test it the animal model and we…   Read more»

]]> 44c1e0887e5979b2346d666d6b934976 https://medicaldevicecourses.com/activity/p/18599/ Sat, 21 Sep 2019 19:45:24 -0400 Let’s start off with industry first. I have done some research in Industry and what I can say is the projects in the  industry do get finished on time and they are successful as well that is because they know what…   Read more»

]]> e7f1b70f3b91335d2bf88cf2d17947a5 https://medicaldevicecourses.com/activity/p/18535/ Sun, 15 Sep 2019 08:57:37 -0400 I have had a very bad experience working under 2 managers. One of the managers was responsible for dispatching the device while the other one was responsible for closing the order. I went for the installation of the device at…   Read more»

]]> 8ed010d2b18e329176ea4cf5d9c4c0b5 https://medicaldevicecourses.com/activity/p/18534/ Sun, 15 Sep 2019 07:45:10 -0400 I was working in a medical device company where I was working on a project where we had an order for a lot of devices, everything was going alright until we found out that the part was not performing the…   Read more»

]]> aaab43da70da3e37ed417b1c71cfb61a https://medicaldevicecourses.com/activity/p/18533/ Sun, 15 Sep 2019 07:29:57 -0400 I believe the initiation and the planning phase is the most important phase in the project management life cycle as most of the things are solidified in that and the next phases fall accordingly.The initiation is the place where we…   Read more»

]]> 9112569ed340f88efffd3133f92dc22b https://medicaldevicecourses.com/activity/p/18471/ Sun, 08 Sep 2019 08:18:41 -0400 Yes, I also think a BS degree is good enough to start within the industry and you work your way up by getting your master’s degree to get the rise in the payscale.The advantage with this is that you know…   Read more»

]]> 0a27237abc53a4fa5858cbc220e9284c https://medicaldevicecourses.com/activity/p/18470/ Sun, 08 Sep 2019 07:36:49 -0400 Personally I feel the ratio should have been 5:5 as a master’s student we already have gone through the basics of Biomedical Engineering in the bachelor’s degree and most of us would want to work in the industry and not…   Read more»

]]> 9783bb464f22af2362d78be0d55789d9 https://medicaldevicecourses.com/activity/p/18469/ Sun, 08 Sep 2019 06:40:08 -0400 I have worked in the industry for 2 years before starting my master’s in the university and having completed 1 year already with my master’s, I can better say the pros and cons of both working in the industry and…   Read more»

]]> f7aeb44535935ac5e2faf951f6f5b040 https://medicaldevicecourses.com/activity/p/18307/ Wed, 15 May 2019 21:47:09 -0400 I think in order to maintain a good relationship with your vendor you should make him understand what product do you want from him. One should know what products the vendor makes other than your product so if at all…   Read more»

]]> 8e4adc183835b87edbfc72514736437d https://medicaldevicecourses.com/activity/p/18306/ Wed, 15 May 2019 21:47:09 -0400 I sincerely feel American workers are motivated to work as here if you put in the hours of work you get paid more. I don’t think they are under any pressure from there peers, its all about going up the…   Read more»

]]> 43b4b570b3eb6664b4b59422c8eb2491 https://medicaldevicecourses.com/activity/p/18305/ Wed, 15 May 2019 21:47:08 -0400 I agree that which CRO to be chosen should depend on the size of trials, the resources, manpower required other than that the cost that they will be charging as well as we have to see if the CRO does…   Read more»

]]> 59f243c1b0433aaafd675fe391385568 https://medicaldevicecourses.com/activity/p/18258/ Wed, 15 May 2019 21:46:45 -0400 The role of an engineer and a manager is very different in terms of the responsibilities each one has to handle, the engineer just has to do the task whatever has been assigned and when done just move on to…   Read more»

]]> 1398a4764163577463756401f2ccdb10 https://medicaldevicecourses.com/activity/p/18257/ Wed, 15 May 2019 21:46:44 -0400 I think the survey is a mix of people from different age groups, different level in the work pyramid and hence it is likely to be diverse and also everybody needs different things in their life but the result dint…   Read more»

]]> 23d095ea86ca0a37e40b8401106f6af5 https://medicaldevicecourses.com/activity/p/18256/ Wed, 15 May 2019 21:46:44 -0400 My motivation is the satisfaction that I experience after I have completed a certain task that is outside my comfort zone as when I handle such tasks I learn a lot of new things and that gives me a sense…   Read more»

]]> 082efccd0e37f2a0c3db0293390ec646 https://medicaldevicecourses.com/activity/p/18183/ Wed, 15 May 2019 21:46:05 -0400 Communication is very much important in the project, the communication management plan is set up so that there is proper communication within the project team as well as with the stakeholders. The project manager should do all the communication between…   Read more»

]]> 5876b93d27957cc48460131468607e27 https://medicaldevicecourses.com/activity/p/18182/ Wed, 15 May 2019 21:46:04 -0400 I should know what are the requirements of my project and what is the role of the material that I am getting from the vendor and see if the product matches the specifications desired. Also, it could be great if…   Read more»

]]> 2f2e13d6d3545cf7b020ffd11e323ff4 https://medicaldevicecourses.com/activity/p/18179/ Wed, 15 May 2019 21:46:03 -0400 I agree with jl959 that even though the project team would agree on a certain communication plan, there needs to be proper communication with the stakeholders as is it would be very late if they suggest a few changes when…   Read more»

]]> 48b497856a494578bd42975159c72684 https://medicaldevicecourses.com/activity/p/18138/ Wed, 15 May 2019 21:45:42 -0400 If it was an emergency situation then nothing could be done as it this was not planned and hence the project will lag because of that but, if it was a planned vacation then the employee would have previously finished…   Read more»

]]> f7ecfe95bf3464bcb253609020884460 https://medicaldevicecourses.com/activity/p/18137/ Wed, 15 May 2019 21:45:42 -0400 I feel it depends on the project we are working on if the project is going to be of great value when it will be on the market in it is ok for me to go a little overboard on…   Read more»

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