Design Controls under FDA's 21 CFR Part 820.30 are all about making sure medical devices are developed with safety, effectiveness, and compliance in mind. They help keep things organized and reduce th...

Great point! It makes sense that every design input should ideally have a corresponding output. Inputs set the foundation—they’re the requirements a device has to meet. In a perfect world, each input ...

You bring up a great point about validation—it’s all about making sure processes can reliably produce a product that meets specific standards. Defining clear success criteria upfront is key; without i...

You've nailed an important point about design controls—they’re all about making sure a medical device is safe and effective by following a structured process. By having these controls in place, manufa...

One of the biggest challenges with multi-center clinical trials is keeping everyone on the same page. Since these trials are all about gathering a lot of data quickly, it’s super important to have cle...

Interestingly, researchers have made it easier to find clinical trials nearby and figure out what to expect if you participate. Clinical trials are crucial in medical research because they help ensure...

Clinical trials are so important for ensuring we develop safe and effective treatments. One treatment that comes to mind is carotid artery stenting (CAS) for patients with narrowed arteries in their n...

You’ve pointed out the connection between sales and marketing pretty well; they really do go hand in hand. Marketing does a solid job of drawing in customers through various channels like social media...

You bring up a great point about the need for long-term customer connections. One effective way businesses can boost customer retention is by creating personalized experiences. Customers who feel unde...

Absolutely! Closing a sale is just the start; the real challenge is keeping customers around for the long haul. Businesses can really up their game by providing personalized experiences, staying conne...

You’ve got a good point about how corporate teams and research labs differ! In a corporate setting, having clear roles and hierarchies can really help with getting things done since everyone knows the...

An extra business course could really help engineering students, especially those looking to get into project management, product development, or even starting their own businesses. While NJIT’s engin...

Regulatory agencies like the FDA and EMA act more like government service organizations than typical businesses. Their main job is to make sure medical products are safe and effective, and they fund t...

For Quality Assurance, two big things that come to mind are regulatory compliance and training. Sticking to regulations like ISO 13485 and FDA guidelines is a must in our industry. Using tools like do...

I don’t have much firsthand experience with root cause analysis (RCA), but I understand its importance in quality management, especially in the medical device industry where safety is a top priority. ...