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Glossary Term

User Requirements

Definition

User Requirements are detailed descriptions of the needs, expectations, and preferences of end-users, such as clinicians, patients, or caregivers, for a medical device. These requirements define the functional, operational, and ergonomic aspects that the device must address to ensure usability, safety, and effectiveness.

Relevance to the MedTech Industry

User Requirements form the foundation of the device design process by ensuring that the product meets real-world needs. They help MedTech companies align their innovations with clinical practices, improve user satisfaction, and reduce the risk of product failure.

Additional Information & Related Terms

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