To effectively reassess and potentially enhance the design controls for a medical device, it is crucial to commence by comprehending the underlying reasons for their existence. This entails delving into the historical context or events that prompted the implementation of…   Read more»

I’ve come to understand that medical device process validation plays a crucial role in ensuring the consistent production of high-quality medical devices. The steps for this validation, which I’ve learned about, include several key components. Firstly, there’s the planning phase,…   Read more»

As a student, I recognize that when developing a medical device in the European Union (EU), the regulatory framework differs from that in the United States. In the EU, there’s no specific obligation to maintain a Design History File (DHF)…   Read more»

In my understanding, validation and verification are distinct processes within product development. Validation entails ensuring that a product effectively meets the requirements and expectations of its customers and users. This crucial step involves external parties, like customers, beta testers, and…   Read more»

I believe that when it comes to attracting participants for clinical trials, it’s crucial to look beyond just monetary compensation. There are various non-monetary incentives that companies and research labs can employ to engage potential participants. These incentives include offering…   Read more»

I understand the significance of having access to clinical trial results when it comes to making informed decisions about one’s health. The availability of such information can vary depending on factors like the country, device type, and manufacturer policies. For…   Read more»

As a student, I’ve learned that emotional intelligence (EI) is the ability to recognize, understand, and manage one’s own emotions and those of others. It’s a vital skill for both personal and professional success. Signs of high EI include being…   Read more»

I’ve had the opportunity to study and observe various clever uses of Participation in marketing. One standout example is Coca-Cola’s “Share a Coke” campaign, which encouraged customers to share a Coke with a friend and share their experiences on social…   Read more»

A mission statement and a vision statement are essential components of a company’s strategic planning and communication strategy. They serve distinct purposes: Mission Statement: A mission statement outlines the fundamental purpose and reason for an organization’s existence. It defines what…   Read more»

I’ve witnessed and been a part of some clever uses of Participation in marketing. One example that stands out is leveraging user-generated content and social media. Brands encourage their customers to create and share content related to their products or…   Read more»

I think they require training in engineering principles as they are marketing something that requires life importance and to professional people such as doctors and surgeons. It also shows transparency or honesty during selling medical products to doctors and professionals….   Read more»

Sole proprietorship cannot shift its owner. Therefore, it is best to change it to LLC and sell all shares to one of his sons. 

I would decline a job offer from a company with a bad reputation, particularly if it had a history of bankruptcy or was involved in the downfall of another company, similar to what happened with Toshiba. On the other hand,…   Read more»

Certainly, I understand your perspective. When I think of corporations, I typically don’t distinguish between S-Corps and C-Corps either, as they both operate under the broader “corporation” umbrella. However, for illustrative purposes, let’s consider two hypothetical companies as examples: One…   Read more»

During my internship at a pharmaceutical company, I had some exposure to Quality Control investigations, where Root Cause Analysis (RCA) was employed to identify and address issues. While I didn’t personally use the Fishbone Diagram method, I did use interviews…   Read more»

I think I agree with that the QA/QC department seems to be a burden.I think that because during the training of the SOPs in the manufacturing process as well as in the QC department, the scientists or associates don’t understand…   Read more»

From my understanding QC and QA are very different but they kinda have the same function as during my working as QC/QA intern at pharma company and manufacturing associate at another one . I was doing investigations in the first…   Read more»

 I believe that the antibiotic-releasing hip stem is combination object that should be classified as a Class III medical device, considering that implants generally fall into this category due to their elevated risk profile. Since the device is regulated by…   Read more»

As a student, I believe that the two approaches to research, academia and industry, each have their own merits and drawbacks. In academia, research tends to be more fundamental and exploratory, focused on advancing knowledge and fostering collaboration across institutions…   Read more»

As a student, I’ve learned that whether missing a project milestone is seen as a failure or a success in terms of improving the overall project depends on several critical factors. First and foremost, the reason behind missing the milestone…   Read more»