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Glossary Term
Design Input
Definition
Design Input refers to the requirements and specifications necessary to develop a medical device that meets user needs, intended use, and regulatory standards. Design inputs are derived from user requirements, clinical needs, risk analysis, and regulatory guidelines and serve as the foundation for the device design process.
Relevance to the MedTech Industry
Design inputs ensure that medical devices are purpose-built to address specific user needs, safety considerations, and performance requirements. They provide a clear roadmap for development and serve as a critical element of design controls, linking user requirements to technical specifications.
Additional Information & Related Terms
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