Activity | ronakmandaliya | Medical Device Courses

ronakmandaliya replied to the topic "Accepting job based on company." – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "Relation of Quality with other department." – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "What are some ways Document Control can improve?" – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "Discussion Topic: The cost of Quality" – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "Precision and Accuracy" – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "Drugs banned in US but not in other countries" – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "FDA rules too strict?" – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "Failure's of Pre-Clinical / Clinical Research" – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "Approaches to Research" – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "Research for the Fututre or Now?" – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "Milestones Missed: Failure or Success?" – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "Discussion Topic: Project Management in a medical device setting" – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic "Project Life Cycle" – 5 years, 11 months ago

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»
ronakmandaliya replied to the topic Matrix Organization- Conflict in the forum Organizational Development in Device Companies 7 years, 4 months ago

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]
ronakmandaliya replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies 7 years, 4 months ago

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]
ronakmandaliya replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies 7 years, 4 months ago

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]
ronakmandaliya replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics 7 years, 4 months ago

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]
ronakmandaliya replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics 7 years, 4 months ago

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]
ronakmandaliya replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 7 years, 4 months ago

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]
ronakmandaliya replied to the topic a successful validation process in the forum Introduction to Design Controls 7 years, 5 months ago

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]
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