What Is Medical Device Shelf Life and How Is It Validated?
Every medical device has a clock running. Shelf life tells you how long that device stays safe and performs as intended before it should be discarded....
How Risk Management Activities Should Be Integrated Throughout Medical Device Development
At MedLaunch, we see proactive risk management as a core part of good medical device development. It supports better design decisions, stronger documentation, and smoother regulatory...
Preparing for the FDA’s 2026 Human Factors Requirements
What the May 2026 FDA human factors guidance means for your medical device 510(k) submission The Food and Drug Administration issued an updated human factors guidance...
ISO 14971: A Clear Guide to Risk Management Systems
Creating a medical device is about more than just innovation; it is about improving lives safely. For new engineers or business leaders transitioning into the medical...