What Are Medical Devices? Types, Classes, Regulation
Medical devices explained: what counts as a device, risk classes, how FDA and EU MDR regulation works, software as a medical device, and post-market surveillance.
A diagnostic test is only as useful as the population it is used in. Sensitivity and specificity are properties of a test; the chance that a positive result is correct depends on how common the condition is among the people being tested.
We report on how tests are validated, what a screening programme is actually trading off, and why a test that performs well in a hospital can perform poorly as a mass screen.
Medical devices explained: what counts as a device, risk classes, how FDA and EU MDR regulation works, software as a medical device, and post-market surveillance.
How medical imaging works: X-ray, CT, MRI, ultrasound, nuclear medicine and PET compared — what each detects, radiation exposure, and how images are interpreted.
Medical diagnostics explained: laboratory tests, molecular and point-of-care diagnostics, imaging, sensitivity and specificity, screening, and companion diagnostics.
How AI supports medical diagnosis and clinical decision-making: imaging, pathology, ECG, risk prediction, validation requirements, and clinician oversight.