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Glossary Term
Intended Purpose
Definition
Intended Purpose refers to the specific function or use of a medical device as defined by the manufacturer. It encompasses the clinical indications, target population, and operational environment for which the device is designed, as outlined in labeling, instructions for use (IFU), or promotional materials.
Relevance to the MedTech Industry
Defining the Intended Purpose ensures that the medical device meets regulatory requirements and is safe and effective for its designated use. It provides clarity to users, regulators, and manufacturers about the scope and limitations of the device, serving as the foundation for compliance and risk management.
Additional Information & Related Terms
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