Medical Device Courses | ronakmandaliya | Activity https://medicaldevicecourses.com/members/ronakmandaliya/activity/ Activity feed for ronakmandaliya. Fri, 24 Apr 2026 21:40:21 -0400 https://buddypress.org/?v= en-US 30 hourly 2 97acbf351b48349cb9fae3c896505b58 ronakmandaliya replied to the topic "Matrix Organization- Conflict" - https://medicaldevicecourses.com/activity/p/14347/ Wed, 15 May 2019 18:55:21 -0400 I have been a part of matrix organization and I have to say it does get bit messy to work, especially when you have two different projects due at same time. If you are good at managing your time it’s…   Read more»

]]> 1b743dc263b46ef8482a0f5de841d78e ronakmandaliya replied to the topic "Upper vs Middle Management." - https://medicaldevicecourses.com/activity/p/14346/ Wed, 15 May 2019 18:55:20 -0400 I think I can probably do both of the described position. However, I definitely need more expereince before I can handle upper managment position. I think I have a bit of experience with a middle management positions in my fraternity…   Read more»

]]> 22c680c51a0f32183e16980eb945d647 ronakmandaliya replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/14345/ Wed, 15 May 2019 18:55:20 -0400 I think its definitely better to work with the people who have more knowledge on their department. As Dr. Schesser has metioned several times in the begining of the capstone project choose a person from each biomedical branch. This is…   Read more»

]]> adbaf0896d4d5cd1068a3b8f60814b68 ronakmandaliya replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/14344/ Wed, 15 May 2019 18:55:19 -0400 Even though, I don’t really have any experience with a big medical device companies I think I can say that I know much about medical device world now then I knew before. I learned a lot from this class, starting…   Read more»

]]> 438b762ef128a76b922147db150d7049 ronakmandaliya replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/14343/ Wed, 15 May 2019 18:55:18 -0400 I think it makes sense that these rules are being placed. you might consider it little too restrictive, but they should be placed. My dad was a doctor in India and he told me the stories about things that these…   Read more»

]]> 00412e8d15ec30101a552b375507aee0 ronakmandaliya replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/14342/ Wed, 15 May 2019 18:55:18 -0400 Personally, I think written agreement is definitely better, because the verbal agreement needs proof of people being there or a video recordings. These proofs can be changed with the current technologies or you can bribe a person to change the…   Read more»

]]> 06f79c29d6bb754cd2e68b1196425428 ronakmandaliya replied to the topic "a successful validation process" - https://medicaldevicecourses.com/activity/p/14030/ Wed, 15 May 2019 18:51:13 -0400 A successful validation process will make sure to follow all the company and the FDA rules and will ensure that the user needs and the company needs are met. The user needs are to make sure that user has everything…   Read more»

]]> 3ee92ede1fecf185323482f5331fd0ca ronakmandaliya replied to the topic "What FDA Looks For In A Design Control System ?" - https://medicaldevicecourses.com/activity/p/14029/ Wed, 15 May 2019 18:51:13 -0400 I think FDA wants to know if the medical device companies are following the Design Control procedure and have valid design control procedure. They need to make sure that this companies have valid protocols they are following, because the main…   Read more»

]]> cfaf3da29a6dfab4fdbb4b16ae6f172c ronakmandaliya replied to the topic "Why VERIFICATION is important? and Your ideas to improve Verification process ?" - https://medicaldevicecourses.com/activity/p/14026/ Wed, 15 May 2019 17:10:32 -0400 I agree with what you have to say about the design verification. It is absolutely necessary to verify design before it goes out for production, because as an industry if you miss even a small thing, it would end up…   Read more»

]]> f3acd679ed9a32e93e062037eb274ff7 ronakmandaliya replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/13909/ Wed, 15 May 2019 17:09:18 -0400 Again, I don’t have any experience on making gantt chart for a company, but I have made gantt chart for my capstone class. I think the first thing to do is the set up the start date and the end…   Read more»

]]> abfa4218da394b89a39bfb65f32608f9 ronakmandaliya replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/13906/ Wed, 15 May 2019 17:09:17 -0400 I have been to few meetings, where minutes are taken, this are really important especially if you are forgetful or busy in general, because you can always look back at it to know what happened in the meeting. The main…   Read more»

]]> 51d42d4af9d60fc0fcb2f8b77b73cbcf ronakmandaliya replied to the topic "Making up tests for design verification and validation" - https://medicaldevicecourses.com/activity/p/13904/ Wed, 15 May 2019 17:09:15 -0400 I did some research on FDA website for this class and before in capstone class and the one thing I found out is that FDA doesn’t care what type of tests you perform as long as you consider all possible…   Read more»

]]> bf8b8f89cf2b1f6cf9c0671712e74739 ronakmandaliya replied to the topic "Manage Risk" - https://medicaldevicecourses.com/activity/p/13753/ Wed, 15 May 2019 17:07:55 -0400 I think it should go like this: 1) Hazards that fall into a low severity risk, are considered generally acceptable and will not require further analysis. 2) The one with the medium severity should be looked over and find the…   Read more»

]]> b69cbb3daf979f089e1109f131e21749 ronakmandaliya replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/13749/ Wed, 15 May 2019 17:07:53 -0400 I think as far as possible, is what is literally should be, because the human life is worth more than anything. We shouldn’t worry too much about cost of making product because people will pay more money with higher qualities…   Read more»

]]> 8b14cd9a00ac791af2ef7b99f7b174b5 ronakmandaliya replied to the topic "Clinical Trial Roles" - https://medicaldevicecourses.com/activity/p/13746/ Wed, 15 May 2019 17:07:52 -0400 I would prefer to be clinical quality assurance, because it gives me chance to go over complete process. It also helps me find different process or find different issues that the whole clinical process could have. Another process I would…   Read more»

]]> 6e35cdca639006d89be0d8de04dc5df4 ronakmandaliya replied to the topic "Marketing Strategy" - https://medicaldevicecourses.com/activity/p/13582/ Wed, 15 May 2019 17:06:15 -0400 One biggest product I have seen is motors used in Dr. Foulds labs. I haven’t seen them on any advertisements on tv or internet. The way I found out about their product is because they sent a sample motor to…   Read more»

]]> 0dbca20be66bcf78a974874de5dcec84 ronakmandaliya replied to the topic "Discussion Topic: Mission and Vision statements" - https://medicaldevicecourses.com/activity/p/13581/ Wed, 15 May 2019 17:06:15 -0400 It’s actually simple. Vision is what do you dream your company to be in the future, while mission things that applies to their customers and works. Ex: johnson and johnson their vision to make helthcare system better, while their mission…   Read more»

]]> 306ca4b494b0579dce7f33f3e1f963b4 ronakmandaliya replied to the topic "Fuzz before launch of product." - https://medicaldevicecourses.com/activity/p/13578/ Wed, 15 May 2019 17:06:13 -0400 I think comparing apple products with me medical device products is a bit of injustice. Apple products in general are made for everyone while medical devices are made for only select group of people such as doctors, patients etc. Apple…   Read more»

]]> f5e56afa38f4d15cf0819f48ccbae528 ronakmandaliya replied to the topic "Types of Corporations" - https://medicaldevicecourses.com/activity/p/13448/ Wed, 15 May 2019 17:04:58 -0400 I would prefer being a partner in a corporation where I hold certain percents of their shares. Because at least that way I don’t have to worry about losing my money while working in a company. I think its too…   Read more»

]]> 285a141b87fb0d89ec82dd0bb064a38e ronakmandaliya replied to the topic "Public vs. Private Companies" - https://medicaldevicecourses.com/activity/p/13446/ Wed, 15 May 2019 17:04:57 -0400 As I mentioned in previous post, I think there is more room for growth in private and small company because the company itself is growing and you grow with it. You learn to become a leader, because you need to…   Read more»

]]> c4866ddfbca50a027108b90b8d4c0c2e ronakmandaliya replied to the topic "Accepting job based on company." - https://medicaldevicecourses.com/activity/p/13444/ Wed, 15 May 2019 17:04:56 -0400 Personally, If I had a similar type of job offer from two different companies, one is a start up and the other is a big corporation and if they both paid me similar amount of money. I would choose the…   Read more»

]]> 0cbf38a318fb567385e3d7d3c98c75f5 ronakmandaliya replied to the topic "Relation of Quality with other department." - https://medicaldevicecourses.com/activity/p/13296/ Wed, 15 May 2019 17:03:41 -0400 I don’t really have any experience with company and what goes on in the company, but from what I learned from the slides and the lecture video, I think the biggest arguments that the Quality Engineers have is with R&D…   Read more»

]]> 353b3cf1ccaa9957e3eed7ed311f17b4 ronakmandaliya replied to the topic "What are some ways Document Control can improve?" - https://medicaldevicecourses.com/activity/p/13294/ Wed, 15 May 2019 17:03:40 -0400 Making sure that both the R&D and quality engineers do their jobs would make it extremely easy improve a document. Besides that, the improvements comes with time. As Dr. Simon mentioned in the presentation, as the company grows in the…   Read more»

]]> a9b60baca997f9c3c4a3abb7f4c6c34f ronakmandaliya replied to the topic "Discussion Topic: The cost of Quality" - https://medicaldevicecourses.com/activity/p/13293/ Wed, 15 May 2019 17:03:40 -0400 In general, the quality is one of the most important part of the company and that is the main reason why jobs for quality engineers are in demand. The best example that related to quality in general is the Ford…   Read more»

]]> bd6957e2fcb1b86ccfc6b070a4db4fb4 ronakmandaliya replied to the topic "Precision and Accuracy" - https://medicaldevicecourses.com/activity/p/13208/ Wed, 15 May 2019 17:02:55 -0400 They are both important to the FDA, because these are the numbers that decide if the device is going to work and how well will it work. For example, if you are inventing a device for chemotherapy it is must…   Read more»

]]> 257f10da944c1bd814d873d1308f5fa0 ronakmandaliya replied to the topic "Drugs banned in US but not in other countries" - https://medicaldevicecourses.com/activity/p/13205/ Wed, 15 May 2019 17:02:53 -0400 I think it is fine that US is doing that and the only reason is because it is really easy to get things passed in countries like India. From experience, as long as you pay people money there, you can…   Read more»

]]> 9750a9c9c066a22f7fa51d5407d3b5e8 ronakmandaliya replied to the topic "FDA rules too strict?" - https://medicaldevicecourses.com/activity/p/13203/ Wed, 15 May 2019 17:02:52 -0400 Yes, the rules are hard and its even harder to go through the process of getting your product pass. However, I believe it is necessary to keep it this way so that big companies don’t take advantage of the process…   Read more»

]]> 0ecb6081fd173c957a195942ebc27865 ronakmandaliya replied to the topic "Failure's of Pre-Clinical / Clinical Research" - https://medicaldevicecourses.com/activity/p/13005/ Wed, 15 May 2019 17:01:10 -0400 I haven’t done any type of pre-clinical or clinical research, but if was to assume, the failure of the research would possibly something quite simple. For example, not following the direction. It could also be something as simple as that…   Read more»

]]> a26e9e70944e3eac6e9c91390d542e2b ronakmandaliya replied to the topic "Approaches to Research" - https://medicaldevicecourses.com/activity/p/12991/ Wed, 15 May 2019 17:01:03 -0400 I am not certainly sure about how the research is approached in industry, but I assume it would be fast paced research, where deadlines has to be met and the research has to be done as fast as possible. While…   Read more»

]]> 0b38f917dc6523dd717699419a219b1d ronakmandaliya replied to the topic "Research for the Fututre or Now?" - https://medicaldevicecourses.com/activity/p/12990/ Wed, 15 May 2019 17:01:02 -0400 Both type of research are important. Personally, I would prefer doing research in academia just because its leisure type of life. I think academia research is just as important because they are trying out different ways until they find a…   Read more»

]]> 74cfe18d6e7b7689a3f6158af67cd22e ronakmandaliya replied to the topic "Milestones Missed: Failure or Success?" - https://medicaldevicecourses.com/activity/p/12836/ Wed, 15 May 2019 16:59:32 -0400 Failing to meet the milestone is in sense considered a failure. However, there should always be a contingency plan if you fail a milestone. Currently, I am taking capstone and we have missed a few milestones, however as long as…   Read more»

]]> 673df564108b63dd9620b4f920b224dc ronakmandaliya replied to the topic "Discussion Topic: Project Management in a medical device setting" - https://medicaldevicecourses.com/activity/p/12835/ Wed, 15 May 2019 16:59:32 -0400 Project manager is both jobs has its own rules and regulations. For example, in medical devices the person has to make sure that the product is safe and able to pass all the FDA regulations. While in construction, they have…   Read more»

]]> 2a203402e45e7b0ce72d98fda1b7f607 ronakmandaliya replied to the topic "Project Life Cycle" - https://medicaldevicecourses.com/activity/p/12814/ Wed, 15 May 2019 16:59:22 -0400 We in reality, all the phases of a project managements are important, because if failing to do one will cause domino effect on the other phases. If we have to choose one, I think it would be initiation phase, because…   Read more»

]]> 0426bc6bea488f52101c410270f5fac3 ronakmandaliya replied to the topic Matrix Organization- Conflict in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5391/ Mon, 27 Nov 2017 17:29:53 -0500 I have been a part of matrix organization and I have to say it does get bit messy to work, especially when you have two different projects due at same time. If you are good at managing your time it’s not really that hard. I only did this type of work a little bit and at lower level so I don’t really know how crazy it could get. In order to make…[Read more]

]]> 0 8689bac74a114ecd38a2adcd4be75c7a ronakmandaliya replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5390/ Mon, 27 Nov 2017 17:24:54 -0500 I think I can probably do both of the described position. However, I definitely need more expereince before I can handle upper managment position. I think I have a bit of experience with a middle management positions in my fraternity and my current work, where I am assigned different projects by the dean of the engineering such as organizing an…[Read more]

]]> 0 ef06dd836b02a89d38913b025441a04f ronakmandaliya replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5389/ Mon, 27 Nov 2017 17:19:27 -0500 I think its definitely better to work with the people who have more knowledge on their department. As Dr. Schesser has metioned several times in the begining of the capstone project choose a person from each biomedical branch. This is necessary because while you are working on a project, you might start hating your friend. If he has different work…[Read more]

]]> 0 999270efc4c0412f9807368fb7345f75 ronakmandaliya replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5388/ Mon, 27 Nov 2017 15:18:52 -0500 Even though, I don’t really have any experience with a big medical device companies I think I can say that I know much about medical device world now then I knew before. I learned a lot from this class, starting from how the company starts making product to the end on how the product is released and all the things in between. After taking this…[Read more]

]]> 0 673f3d8e8ddb65b32fd7b084430101e1 ronakmandaliya replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5387/ Mon, 27 Nov 2017 15:06:40 -0500 I think it makes sense that these rules are being placed. you might consider it little too restrictive, but they should be placed. My dad was a doctor in India and he told me the stories about things that these big companies offered him for prescribing their medicines. They used to host dinner every week for the families of almost all the doctors…[Read more]

]]> 0 505f74d757d09764896d54e6035ce23a ronakmandaliya replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5386/ Mon, 27 Nov 2017 14:56:00 -0500 Personally, I think written agreement is definitely better, because the verbal agreement needs proof of people being there or a video recordings. These proofs can be changed with the current technologies or you can bribe a person to change the statement. The written agreement, is the best way to go because you have everything listed from what you…[Read more]

]]> 0 c04e75d2c433ef32e2573442d3fd3bc5 ronakmandaliya replied to the topic a successful validation process in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5053/ Mon, 13 Nov 2017 02:26:19 -0500 A successful validation process will make sure to follow all the company and the FDA rules and will ensure that the user needs and the company needs are met. The user needs are to make sure that user has everything they expect in the product, while the comapny needs are to make sure that the company makes profit. A good validation plan to target…[Read more]

]]> 0 c5a3e32225624125464cf8a6a4130644 ronakmandaliya replied to the topic What FDA Looks For In A Design Control System ? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5052/ Mon, 13 Nov 2017 02:18:29 -0500 I think FDA wants to know if the medical device companies are following the Design Control procedure and have valid design control procedure. They need to make sure that this companies have valid protocols they are following, because the main purpose of this is to know that this devices won’t harm anyone. They are as follows: planning, input and…[Read more]

]]> 0 d2cce84a74d277b6f98a1cf0e87a1f31 ronakmandaliya replied to the topic Why VERIFICATION is important? and Your ideas to improve Verification process ? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5050/ Mon, 13 Nov 2017 02:10:26 -0500 I agree with what you have to say about the design verification. It is absolutely necessary to verify design before it goes out for production, because as an industry if you miss even a small thing, it would end up costing you millions, if not billions to repair the fault. If the device is harmful it will hurt the company even more, because they…[Read more]

]]> 0 e3e6a688884f6a3bf3e58743103843d2 ronakmandaliya replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/4919/ Mon, 06 Nov 2017 03:13:26 -0500 Again, I don’t have any experience on making gantt chart for a company, but I have made gantt chart for my capstone class. I think the first thing to do is the set up the start date and the end date of the project. After that, you should find out what the critical tasks are. When making the gantt chart, give as much time as possible for each…[Read more]

]]> 0 464078ef08a5768dfdfc34a4c442a492 ronakmandaliya replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/4916/ Mon, 06 Nov 2017 03:01:28 -0500 I have been to few meetings, where minutes are taken, this are really important especially if you are forgetful or busy in general, because you can always look back at it to know what happened in the meeting. The main reason for this is, because lots of tasks are assigned during the meetings. People have finish this task by given deadline. This…[Read more]

]]> 0 cb806933b636e1cc949e3a2b5df7f12f ronakmandaliya replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/4914/ Mon, 06 Nov 2017 02:51:12 -0500 I did some research on FDA website for this class and before in capstone class and the one thing I found out is that FDA doesn’t care what type of tests you perform as long as you consider all possible tests and perform them. I think it makes sense because as you mentioned it, every product should have different test because of their biology,…[Read more]

]]> 0 4413eb7290ec3e810b4933e3808217c1 ronakmandaliya replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/4617/ Sun, 29 Oct 2017 22:17:46 -0400 I think it should go like this:
1) Hazards that fall into a low severity risk, are considered generally
acceptable and will not require further analysis.
2) The one with the medium severity should be looked over and find the problem and mitigate it.
3) Hazards that fall into a high severity risk, are generally unacceptable. If
hazards at these…[Read more]

]]> 0 2fd46974dba374093ffcf30486d6ad20 ronakmandaliya replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/4613/ Sun, 29 Oct 2017 22:00:33 -0400 I think as far as possible, is what is literally should be, because the human life is worth more than anything. We shouldn’t worry too much about cost of making product because people will pay more money with higher qualities than pay less for a product that could be harmful for you. It will also end up costing you too much money if you get…[Read more]

]]> 0 544a6b890d61ab4cb180927f625843c8 ronakmandaliya replied to the topic Clinical Trial Roles in the forum Clinical Research Basics https://medicaldevicecourses.com/activity/p/4610/ Sun, 29 Oct 2017 21:30:03 -0400 I would prefer to be clinical quality assurance, because it gives me chance to go over complete process. It also helps me find different process or find different issues that the whole clinical process could have. Another process I would prefer is being principal investigator, because it will give me a chance to look over the study and help the…[Read more]

]]> 0 89102ef7d0599d8ded6696a052f0ed22 ronakmandaliya replied to the topic Marketing Strategy in the forum Marketing and Sales https://medicaldevicecourses.com/activity/p/4301/ Sun, 22 Oct 2017 18:47:25 -0400 One biggest product I have seen is motors used in Dr. Foulds labs. I haven’t seen them on any advertisements on tv or internet. The way I found out about their product is because they sent a sample motor to Dr. Foulds lab as an advertisement. After see that motor, Dr. Adamovich bought similar motor for his research. Another example, I think is…[Read more]

]]> 0 fd051ff36aa82b7c9a616aafeb67fbc0 ronakmandaliya replied to the topic Discussion Topic: Mission and Vision statements in the forum Marketing and Sales https://medicaldevicecourses.com/activity/p/4300/ Sun, 22 Oct 2017 18:42:58 -0400 It’s actually simple. Vision is what do you dream your company to be in the future, while mission things that applies to their customers and works. Ex: johnson and johnson their vision to make helthcare system better, while their mission is Caring for the world, one person at a time.

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