Having a solid plan in place for emergencies is definitely a smart move. If something happened to me, I’d want a clear roadmap for how things should be handled—like managing deals and legal stuff—so t...

To strike a good balance between protecting sensitive information and being transparent when working with consultants, companies need a thoughtful approach. NDAs should be specific and focus on truly ...

In manufacturing, risk management is all about catching potential issues early to keep things running smoothly and safely. While avoiding risks is a big focus, there are also other strategies like red...

A key but often overlooked part of risk management in medical devices is human factors engineering (HFE). While frameworks like ISO 14971 help address device risks, HFE focuses on how users interact w...

When developing medical devices, figuring out what level of risk is acceptable comes down to balancing patient safety, technology, and costs. It involves doing a risk-benefit analysis, applying the AL...

Managing a big, complex Design History File (DHF) can definitely be tricky, but one good way to handle it is by keeping things organized. Breaking it down into clear sections that follow the product d...

Design Transfer is a key part of moving from development to manufacturing, and there are a few ways companies can improve it to avoid production issues and keep quality up. First, making sure the desi...

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...