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Glossary Term
Class I Medical Devices
Definition
Class I Medical Devices are the category of medical devices that pose the lowest risk to patient safety. These devices are subject to the least regulatory oversight, typically requiring general controls for compliance. Examples include bandages, examination gloves, and manual surgical instruments.
Relevance to the MedTech Industry
Class I devices provide essential tools and materials that support healthcare delivery. Their straightforward regulatory requirements allow for faster market entry while maintaining safety and efficacy through general controls.
Additional Information & Related Terms
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