CAPA vs. Correction: When Does a Quality Issue Need More Than a Fix?
Every medical device company runs into quality issues from time to time. Sometimes a component might fail a test, while other times a supplier could deliver...
Does a Change to a Medical Device Require a New 510(k)?
Medical devices rarely stay the same after they receive clearance from the FDA. New breakthroughs, design tweaks, software updates, and manufacturing improvements happen all the time....
Do Wellness Devices Need FDA Approval?
Wellness devices do not require FDA approval or premarket clearance if they promote general wellness or healthy activity and present a low risk to users without...
How Does IEC 60601 Fit Into an FDA Submission Strategy?
IEC 60601 plays a central role in your FDA submission strategy for any device with electrical or electronic parts. The FDA recognizes IEC 60601 as a...
What FDA Rules Apply to Remote Patient Monitoring (RPM) Devices?
Remote patient monitoring lets clinicians track a patient's health data outside the traditional clinic, from heart rate and glucose levels to blood pressure and oxygen saturation....
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....
- 1
- 2
- 3
- 4
- …
- 9
- Go to the next page