When designing and conducting clinical trials, researchers must prioritize ethical principles that protect the participants' rights alone with their well-being, while simultaneously maintaining scient...

There are several reasons someone might want to join a clinical trial, and I will briefly speak about a couple examples. As new treatments are continuously being developed and released, many individua...

Post market research is necessary due to several factors, one being the variability in patient demographics. Clinical trials are important as they give a basis of information, but they often exclude c...

Based on my background as a biomedical engineer and the skills I gained in my specific track, my skillset would best fit the subset of product management. My technical expertise provides a strong foun...

A great real-world example to look at is the COVID-19 vaccine. If you look specifically at Moderna. who is known for their mRNA technology, both their internal and external environments affected decis...

My SWOT analysis of a start-up stent company is as follows: Strengths - The innovative technology and advanced material is able to enhance the performance and durability of the internal stent signific...

Hi Cassie, you are absolutely correct. A sole proprietorship is indeed an unincorporated personal business, not a corporation. A sole proprietorship is essentially an extension of the individual who o...

Regulatory agencies like the FDA and EMA are interesting because while they are government organizations, they operate with many similarities to a business. They are responsible for ensuring the safet...

If I were given the opportunity to build my own business, I would focus on creating a venture rooted in innovation and adaptability and align it with current technological trends. Due to my personal i...

To answer the overarching question: yes. Audits play a critical role in assessing whether QA and QC are following proper protocols. However, they are only part of a much broader system for ensuring co...

Several key challenges are met when trying to ensure medical device safety and efficacy in the face of advancing technology and shifting regulations. For example, rapid innovation, especially with com...

I agree with the points above about the importance of quality assurance and control in ensuring a product's safety and effectiveness throughout the production process. In addition to this, I also want...

Both product development and post-market management are critically important to the regulatory process, but they impact projects in different ways. Product development is important for ensuring medica...

The classification of an adhesive designed for interna use in medical devices on several factors, including the intended application, the materials used, and how the adhesive will interact with the bo...

I think the way the FDA handled the COVID-19 vaccine rollout from 2020-2021 was a significant achievement, although it had its flaws. They were able to balance the urgency by the government and public...