Some examples of device changes that need to be controlled are updates to the materials used, switching suppliers, or adjusting a device’s size or shape. Even small changes like replacing adhesives, u...

I think it really depends on the company and how much they value quality in their process. Some teams tend to see design controls as just another set of documents to complete for FDA or ISO compliance...

A contract manufacturer has a lot of responsibility when it comes to process validation. Besides qualifying multiple machines and setting up preventive maintenance, they should also provide clear IQ, ...

That’s a really good point about catching design issues early and I actually can relate. From my experience during my internship, I’ve seen how important proper documentation is, even though it can fe...

Design control is definitely one of the most important parts of developing a medical device because it helps ensure safety, effectiveness, and regulatory compliance. But when it’s not applied properly...

From my experience as a QC/QA intern at Case Medical, I’ve seen how validation and verification are similar but serve different purposes. Verification is more about checking that a product was made co...

If I were involved in clinical research, I would want to take on the role of a Clinical Investigator because it connects closely with the kind of work I already do as a Quality Engineering intern In m...

That is actually a really good question, and I agree with most of the responses because it seems reasonable to think that only the patient needs to be unaware of what treatment they are receiving. The...

Clinical studies are a vital part of medical progress because they test whether years of lab research can actually improve real lives. For example, the covid 19 vaccine trials showed how research can ...

Medical device companies can build trust with both doctors and patients by creating marketing that focuses on education, honesty, and transparency. For doctors, trust grows when companies share clear,...

When I think about branding and color, it’s clear that companies put a lot of thought into how people emotionally respond to what they see. In the medical field, I often notice brands using shades of ...

Cook Medical Mission: Cook Medical’s mission is to provide innovative and minimally invasive medical devices that improve patient care and advance healthcare around the world. Vision: While Cook Medic...

I think an engineer or scientist can absolutely start a successful business without an MBA. While business school offers useful connections and credibility, most of what you need to run a company can ...

If a father owns a sole proprietorship and wants his two sons to continue the business, he would need to restructure it since a sole proprietorship cannot be transferred to others. One option would be...

I think most engineering students could benefit from learning a bit more about the business side of things. The engineering management class does a nice job introducing project management and basic ec...