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Glossary Term
Class III Medical Devices
Definition
Class III Medical Devices are high-risk devices that are critical to sustaining or supporting life, are implanted, or pose significant potential risk to patients if they fail. These devices require the most stringent regulatory oversight, including extensive clinical evaluations, comprehensive risk management, and rigorous conformity assessments by regulatory bodies. Examples include pacemakers, implantable defibrillators, and artificial heart valves.
Relevance to the MedTech Industry
Class III devices provide essential solutions for life-sustaining, life-saving, or high-impact therapeutic and diagnostic applications. Their development demands robust scientific evidence and strict compliance to ensure patient safety and efficacy.
Additional Information & Related Terms
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