It is possible that teams log additional design inputs beyond the requirements for different reasons, including predictive measures, future risk prevention, or preparing for later iterations of the product. The goal is typically to meet the essential inputs for verification…   Read more»

A DHF can become overwhelming if not managed correctly. Some ways to mitigate this are to organize the DHF by development phase to make it easy for any reader to follow the development process, group together similar types of documents…   Read more»

Validation processes such as testing and verification are if utmost importance to product development across all industries. In my experience, these processes play a crucial role in identifying defects early, confirming the product meets user requirements, and building confidence in…   Read more»

In clinical trials, effective communication among sponsors, investigators, CROs, and IRBs is crucial when handling unexpected adverse events. I believe that it would be beneficial to have a standardized, predefined process for addressing unexpected adverse events, but there is also…   Read more»

I think in most cases it is appropriate to offer patients in a clinical trial payment for their participation. Being involved in a clinical trial often involves time and travel of being treated and coming back for check-ups, which can…   Read more»

There are many ethical issues that could arise when using AI in clinical trials. When it comes to selection of participants, it is possible for AI systems to unintentionally show bias based on the data that was used to train…   Read more»

In the medical device industry, the emphasis on trust and long-term relationships is critical. It is the role of a good sales representative to build this long-term trust by providing quality service and personalized support. Besides gift giving and taking…   Read more»

Story telling is an effective strategy for brands to create customer loyalty because it is a way for them to connect with their customers on a personal level. I know that I have definitely fallen victim to these types of…   Read more»

Customer retention is an extremely important aspect of running a successful business. Some strategies that businesses can use to for customer retention include personalized communication, being receptive to feedback, and overall excellent customer service. Businesses should strive to make each…   Read more»

The best type of corporation structure for a business depends on what the intentions of the corporation are. Some factors to consider when choosing a business structure are the size of the business, management style, risk level, and growth goals….   Read more»

Business knowledge can be a very beneficial edge to have as an engineer, but I do not think that it is possible to require much more than what is currently required in the curriculum. With all of the required engineering…   Read more»

There are many differences between working at a public or private company as an engineer. In public companies, there is pressure from shareholders and financial reporting. These factors can influence engineers’ work because they may be under pressure to cut…   Read more»

This post raises some interesting points about the role of QA/QC in ensuring compliance and product quality within an organization. When a company goes through an audit, they are essentially being checked on the effectiveness of their quality systems. The…   Read more»

Personally, I would not describe AI and machine learning as a disruption to industry jobs. AI can turn into a valuable tool for companies who embrace and learn how to work with it. Using AI, quality departments can create AI…   Read more»

In the context of rapidly evolving technology and regulatory standards, many challenges can arise related to quality control. Regarding evolving technology, quality control must perform continuous risk analysis to look out for new risks that may pop up associated with…   Read more»

The 510(k) process can be beneficial and stimulate innovation in many ways. Just because companies may be comparing their device to a device that is 40 years old, if the existing device still works then I do not see an…   Read more»

It is true that a lot of FDA approved drugs or devices may come with risks or serious side effects even though they have been approved as “safe”. One aspect of drug usage that the FDA cannot do much to…   Read more»

In my opinion, technology has the potential to improve regulatory practices in industry in a multitude of ways. A few ways that technology can improve regulatory practices include streamlining processes, automated data analysis, and real time analytics. Automation tools and…   Read more»

There are many factors that can contribute to why dental implants are so expensive. First of all, although they may seem small compared to other devices of similar price, the materials and process that goes into getting the implant prepared…   Read more»

Finding balance between research and ethics is an extremely important aspect of designing a study. There are strict guidelines governing when it is allowable to use animals in research. As a general rule, animal testing should always be considered as…   Read more»