Medical device

A product intended to diagnose, prevent, monitor, or treat a medical condition without primarily acting through chemical means. It can be an instrument, implant, apparatus, software, or other product.

Intended use: The purpose and conditions of use specified for a product by its manufacturer. It anchors whether a product falls within the medical-device definition and shapes its regulatory pathway.
Medical imaging: Techniques that create images of internal structures or processes for diagnosis or treatment. Imaging devices convert physical signals into views clinicians use to guide decisions.
Diagnostic test: A procedure or measurement used to identify or assess a disease or health condition. Diagnostic devices produce measurements or results that inform disease identification.
Clinical trial: A research study involving human participants that evaluates medical interventions or procedures. Clinical investigations can establish whether a device is safe and performs as intended.
Medical device classification: The assignment of medical devices to regulatory categories based on risk and intended use. It determines the controls applied to devices with different levels of potential harm.
Electrocardiography: The recording of electrical activity generated by the heart over time. An electrocardiograph detects and records cardiac signals through skin electrodes.
Implantable medical device: A medical device placed within the body through surgery or another medical procedure. Implants remain in the body to restore function, deliver therapy, or monitor health.
Quality management system: A formal system of processes and responsibilities used to consistently meet quality requirements. Manufacturers use quality systems to control design, production, and corrective actions.
Risk management: The systematic identification, evaluation, and control of risks associated with a product or activity. Device safety depends on managing hazards across design, manufacture, and use.
Pulse oximetry: A noninvasive method for estimating arterial oxygen saturation from light absorption through tissue. The pulse oximeter illustrates optical measurement used for physiological monitoring.

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