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archishak
@archishak
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Joined: Sep 5, 2023
Last seen: Apr 17, 2024
Topics: 0 / Replies: 71
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RE: Design Output

You are correct in the sense that every input in the design control process should have an output. However, some companies do not and one of the reaso...

1 year ago
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RE: Initializing Design Controls

The first and most important part to implement would be to create a well-structured and communicated process for the change that will be occurring. Th...

1 year ago
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RE: Design Input Requirement Categories

The medical device that I will be discussing is the digital blood pressure monitor. The functional requirement of this device would be that the devi...

1 year ago
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RE: Clinical Trial Phase 2 Observations

Phase 2 of a clinical trial is crucial for testing new medications. It is during this phase that researchers observe the effect of the drugs being tes...

1 year ago
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RE: Tests and treatments involved in clinical trials

A specific testing used in clinical research within the medical device industry is the Premarket Approval (PMA) process. The purpose of this process i...

1 year ago
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RE: Double Blind Experiment for Fibroids

Following the previous reply, having a double-blind clinical trial would reduce any bias seen in a research study. To conduct a double-blind study for...

1 year ago
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RE: SWOT Analysis for Medical Device Start-Up

For the scenario of stents, here is a SWOT analysis: Strengths: since there is a large need in the US for improved stents, this start-up company has...

1 year ago
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RE: Marketing Clinical trials And Recruitment

Recruiting diverse and underrepresented populations for clinical trials is crucial for the development of equitable healthcare solutions. It can be ch...

1 year ago
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RE: Marketing and Advertising: Can the two collide?

I believe that medical device development industries use targeted digital marketing strategies of advertising on select channels to reach a target dem...

1 year ago
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RE: LLP vs LLC

Limited Liability Companies (LLCs) and Limited Liability Partnerships (LLPs) are both legal business structures that provide liability protection for ...

1 year ago
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RE: Ethics of Corporation considered as an entity

When it comes to corporations and considering them as moral entities, there are various points of view that should be taken into consideration. From a...

1 year ago
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RE: Business Courses for Engineering Students?

I believe additional business courses should be available as electives rather than required courses. Engineering students can follow many different ca...

1 year ago
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RE: Quality Assurance Job Example

I believe that involving clients in the developmental stages of a medical device can be highly beneficial. Some reasons as to why include, the impleme...

1 year ago
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RE: QA/QC for a Medical Device Project

Quality assurance (QA) and quality control (QC) are crucial aspects of medical device development. 2 factors that influence QA are regulatory complian...

1 year ago
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RE: Product Labeling

The responsibility of addressing a damaged label depends on several factors on how the damage occurred. For example, if the damage occurred during han...

1 year ago
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