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Chris Vasquez replied to the topic "Factors Contributing to Risk Values" – 5 years, 11 months ago
I do agree with the comment above, how severe a failure is by looking at the nature of the harm is a very important aspect. In addition, other factors that may potentially determine risk would be: 1) Vulnerability- which relates… Read more»
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Chris Vasquez replied to the topic "Risk management and Labels" – 5 years, 11 months ago
With respect to medical devices that are used during surgery, lab technicians should be properly trained in aseptic technique, and both surgeons and lab technicians should be aware of how there devices function. I know for one product in the… Read more»
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Chris Vasquez replied to the topic "Risk analysis in real company" – 5 years, 11 months ago
I haven’t had formal experience with risk analysis, but from what I understand of the risk methodology is that it incorporate all cross functional teams within the products development. Whether if it’s marketing or R&D Engineering, the concept of Risk… Read more»
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Chris Vasquez replied to the topic "Design Review Meetings" – 5 years, 11 months ago
I have never actually been involved in a design review meeting, but I know from my experience within R&D and now in manufacturing. To me meeting minutes are essential with regards to project deadlines or even addressing potential issues or… Read more»
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Chris Vasquez replied to the topic "Consequences Of Insufficient Design Controls" – 5 years, 11 months ago
Hi Lamiaa, If design controls are not adequately used often time the concluding result would be the termination of the project if it’s in early phases or if it’s an approved project this could lead to lower quality product. Design… Read more»
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Chris Vasquez replied to the topic "Minutes for meetings" – 5 years, 11 months ago
Hi Roberto, Meeting notes are important with respect to relaying critical information on projects to creating timelines for projects. I know in my experience, during these meeting we update the team on statuses of projects, revise timelines with deliverables. Lastly,… Read more»
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Chris Vasquez replied to the topic "Making up tests for design verification and validation" – 5 years, 11 months ago
As many have mentioned before verification and validation often come hand in hand, and they sometimes are used interchangeable, but they are different. Combined verification and validation of engineering designs within the product lifecycle directly influence production performance, define product… Read more»
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Chris Vasquez replied to the topic "What are Design Controls?" – 5 years, 11 months ago
Design controls are required by the FDA and are implemented to ensure traceability on released products. The idea is that if the released product has a defect which interferes with its function and effects the consumer, all history is traced… Read more»
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Chris Vasquez replied to the topic "Consequences Of Insufficient Design Controls" – 5 years, 11 months ago
Design controls are essentially implemented to ensure traceability on their released product. The idea is that if the released product has a defect which interferes with its function and effects the consumer, all history of the product from design to… Read more»
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Chris Vasquez replied to the topic "Design Verification & Validation" – 5 years, 11 months ago
In terms of verification it can be a considered a form of quality control in which processes, services or documents conform to specified requirements or regulations from the vendor, which may also be attributed within Installation qualification, which ensures that… Read more»
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Chris Vasquez posted a new topic "Holistic Qualification" – 5 years, 11 months ago
Hi All, I was wondering if anyone knew of the concept of a Holistic Qualification/ Holistic Approach for Qualification, I know by definition it is done at the user site and it involves the entire instrument and software system. I… Read more»
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Chris Vasquez posted a new topic "SOP: how much detail before too much detail?" – 5 years, 11 months ago
Hi All, Currently I am updating a few SOPs, some of them are having a complete rewrites and the technology has drastically changed since its last revision. As a result, some of the SOP that I am writing have a… Read more»
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Chris Vasquez replied to the topic Consent and predicted outcome in the forum Clinical Trials for Medical Devices 7 years, 11 months ago
It’s really hard to have a animal study fully represent the potential effects of a drug/medical device within a human. There are so many variables within a human that can drastically effect how the drug/medical device will respond or more importantly how those items will effect the body. In the case where unexpected results occur, there could be a…[Read more]
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Chris Vasquez replied to the topic AMDD in the forum Clinical Trials for Medical Devices 7 years, 11 months ago
As someone who is starting there career within the medical device industry and applying what was learned in class, I felt that applying my knowledge from class concurrently with the application aspect helps me to fully understand what goes on within this type of industry. I personally work within the validation aspect, and it was great having the…[Read more]
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Chris Vasquez replied to the topic Simulation Experience in the forum Clinical Trials for Medical Devices 7 years, 11 months ago
As someone who has worked within the medical device industry and consumer, these simulation have reminded me of the type of typical day to day problems/issues that could potentially occur. Their could be multiple approaches to solve these simulations, which happens in real life as well, some solutions may be better than others. Overall, this…[Read more]
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Chris Vasquez replied to the topic Disconnect in rewarding motivation in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
I have seen it myself sometimes the area disconnect, when I worked in consumer, I saw the constant push on the release of product from upper management, but never the recognition of a great job. I have seen that contracts to external manufacturers were implemented just because of the good relationship they had with an individual in upper…[Read more]
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Chris Vasquez replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
Great question, but I am quite sure where ideally I would like to end up. Ideally, I would like to work as an engineer for a few years… gain experience within the field and develop my career. Ideally after maximizing my options through engineering, I would like to take a manager role. I don’t know exactly what type of manager role I would like…[Read more]
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Chris Vasquez replied to the topic Why do people leave work? in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
I know a few people that had a fear of feeling ” too comfortable” at work, sometimes you adjust to a certain rhythym and just conform, as a result they move around to another position. Currently, I am transitioning from a co-op to a employee position. So I am currently at that excited state to begin my engineering career, at probably one of my…[Read more]
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Chris Vasquez replied to the topic career path in the forum Clinical Trials for Medical Devices 7 years, 11 months ago
I would really enjoy going into R&D, but not within the clinical research area. I feel that this aspect within industry is probably one of the toughest. I attached a link to a website that talks about the pros and cons for clinical research associates.
https://uihc.org/pros-and-cons-clinical-research -
Chris Vasquez replied to the topic Unexpected Clinical Study Results in the forum Clinical Trials for Medical Devices 7 years, 11 months ago
Well in my opinion it depends, whether its as a result of the trial itself or the manufacturer of the drug. As the comments mentioned above, there could be an investigation on the drug, which find components to be not safe and as a result the trial is cancelled. Vice versa could be said about the trial itself… if something unexpected occurs.
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