Design control is a sensitive and important task in medical device manufacturing companies. The protocol to undergo design control and review can be considered a milestone in meeting regulatory norms and standards. This helps with product failure, rejection, mall function,…   Read more»

Enhanced Data Security and Patient Privacy:  Likewise FDA, medical companies have to follow HIPAA regulations. If the device is connected to a software operation, software validation protects the patient’s sensitive and personal information. Software validation and authentication guards prevent patients’…   Read more»

Medical device manufacturing companies have more crucial and sensitive responsibilities than other corporate sectors. Medical devices have a direct impact on the health and wellness of society. Despite medical companies abiding by FDA or ISO standards, new or small companies…   Read more»

Payment gives recognition to the participants’ time and risks, which enhances the recruitment process, and boosts diversity. On the other hand, ethical concerns regarding coercion arise. Financial incentives may lead the most vulnerable people to participate in studies for the…   Read more»

A double-blind study design is crucial in clinical trials to eliminate biases that can distort results. The fact that a single-blind study reduces participant bias does not account for the influence of the investigators themselves. If the researchers are aware…   Read more»

I would say, product development focuses on creating new products through research and innovation and mainly turning ideas into real solutions or prototypes that meet one’s customer needs. On the other hand, product management looks over a product’s life cycle…   Read more»

I agree that sales and marketing are fantastic fields for people who enjoy working with people. Although I haven’t directly worked in these areas, I see how essential they are for any business. marketing creates brand awareness through various channels,…   Read more»

In my opinion, as a newcomer, my first priority would be to secure a position that allows me to learn as much as I can. I believe job satisfaction is essential, and I want to ensure I can give my…   Read more»

It is very true and important that taking a business course would definitely benefit engineering students entering the industry. However, rather than requiring a full semester-long course, offering certifications could be a more effective approach. Certifications allow students to learn…   Read more»

I agree and personally, choosing a company to work for my top priorities are stability, opportunities for growth, and strong employee benefits. Large companies offer these through competitive pay and plenty of chances for career development. I also like the…   Read more»

QC plays an important role in making sure that processes and products meet their respective standards. I think planning the workflow can save a significant amount of time. For instance,  when working on an experimental task or assays where collecting…   Read more»

Root cause analysis is a method that deals with quality management to find the root cause of a problem, rather than just addressing the issues. With a little experience as an engineering coop in a medical manufacturing company, I think…   Read more»

Quality Assurance (QA) and Quality control (QC) in medical devices as both essential but serve different roles.  As learned in this week’s lecture, QA ensures that the process used during development follows safety standards, like ISO, and focuses on managing…   Read more»

I think and agree that as technology evolves, the devices will also integrate them and evolve, which is technically for the betterment of humankind. Any device that was considered safe years back would be true, but later there might be…   Read more»

Yes, I agree that, as most have mentioned, funding is the first and foremost step to get started with the initial process. however, in my opinion, based on my small co-op experience working with a medical device manufacturing company, I…   Read more»

Precision and accuracy are the most important aspects that need to be examined very carefully to make sure the data is as close as possible with very little tolerance. Especially for biomedical implants/devices, it’s definitely something that cannot be let…   Read more»