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...
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....
What Is QMSR (Quality Management System Regulation)?
If you manage quality or regulatory work for a medical device company, you have probably heard that the FDA changed its rules. The shift from the...
How Manufacturing Process Controls Affect Medical Device Compliance
At MedLaunch, we see manufacturing process controls as a direct link between product quality and regulatory compliance. A strong design can still run into trouble if...
What to Expect During an FDA Quality System Inspection
As a medical device developer, when the time comes for an FDA inspection, it is entirely normal to feel a surge of pressure. Complex regulations and...