A medical device is anything from a tongue depressor to an implanted defibrillator to a piece of diagnostic software. That range is why device regulation is tiered by risk rather than applied uniformly, and why "approved device" means very different things in different classes.
We cover how devices reach the market, how they are monitored once there, and where the rules were written for hardware and now have to cover software.
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.
Robotic surgery explained: how surgical robots work, where they are used, evidence on outcomes, training and costs, and what autonomy in the operating room means.
How medical device innovation works: needs identification, prototyping, design controls, risk management, clinical evaluation, regulatory approval and adoption.
How medical device regulation works: risk classification, FDA pathways, EU MDR and notified bodies, clinical evidence, software rules and post-market surveillance.