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Glossary Term
Device Tracking
Definition
Device Tracking refers to the process of monitoring the location, usage, and distribution of medical devices throughout their lifecycle to ensure accountability, safety, and regulatory compliance. It involves maintaining records of devices from manufacturing to delivery and, in some cases, through post-market use or disposal.
Relevance to the MedTech Industry
Device tracking ensures that manufacturers and healthcare providers can locate and manage medical devices efficiently, particularly in the event of recalls, adverse events, or maintenance needs. It is a regulatory requirement for certain high-risk devices to protect patient safety and maintain compliance with standards such as FDA 21 CFR Part 821.
Additional Information & Related Terms
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