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 reasons could be because of the simplistic nature of th...

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. This can be done through several steps starting with...

The medical device that I will be discussing is the digital blood pressure monitor. The functional requirement of this device would be that the device should accurately measure systolic and diastolic ...

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 tested on a small group of people for an extended per...

A specific testing used in clinical research within the medical device industry is the Premarket Approval (PMA) process. The purpose of this process is to evaluate and ensure that the medical device a...

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 research regarding fibroids in black women, the f...

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 a substantial growth opportunity for reaching its t...

Recruiting diverse and underrepresented populations for clinical trials is crucial for the development of equitable healthcare solutions. It can be challenging to do so in a proper fashion. If I were ...

I believe that medical device development industries use targeted digital marketing strategies of advertising on select channels to reach a target demographic/audience. By doing so, companies can tail...

Limited Liability Companies (LLCs) and Limited Liability Partnerships (LLPs) are both legal business structures that provide liability protection for their owners. A choice between LLC and LLP depends...

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 legal status point of view, corporations are view...

I believe additional business courses should be available as electives rather than required courses. Engineering students can follow many different career paths that may not include the need to incorp...

I believe that involving clients in the developmental stages of a medical device can be highly beneficial. Some reasons as to why include, the implementation of user-centered designs, having early fee...

Quality assurance (QA) and quality control (QC) are crucial aspects of medical device development. 2 factors that influence QA are regulatory compliance, ensuring that the device is compliant with reg...

The responsibility of addressing a damaged label depends on several factors on how the damage occurred. For example, if the damage occurred during handling/shipment of the product then it would be the...