When it comes to agreements, one of the most important things is making sure everyone knows what’s expected from the start. For example, in consulting...

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 b...

To strike a good balance between protecting sensitive information and being transparent when working with consultants, companies need a thoughtful app...

In manufacturing, risk management is all about catching potential issues early to keep things running smoothly and safely. While avoiding risks is a b...

A key but often overlooked part of risk management in medical devices is human factors engineering (HFE). While frameworks like ISO 14971 help address...

When developing medical devices, figuring out what level of risk is acceptable comes down to balancing patient safety, technology, and costs. It invol...

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 ...

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 issue...

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 m...

Great point! It makes sense that every design input should ideally have a corresponding output. Inputs set the foundation—they’re the requirements a d...

You bring up a great point about validation—it’s all about making sure processes can reliably produce a product that meets specific standards. Definin...

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 ...

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...

Interestingly, researchers have made it easier to find clinical trials nearby and figure out what to expect if you participate. Clinical trials are cr...

Clinical trials are so important for ensuring we develop safe and effective treatments. One treatment that comes to mind is carotid artery stenting (C...