Design Input Requirements
Phase 2
What are Design Input Requirements (DIR)?
Design Input Requirements (DIR) translate user needs into engineering-level specifications. In medical device development, user needs are the critical capabilities or deliverables that a medical device provides to its users. DIRs ensure that these needs are met by defining the specific functionalities and performance criteria the device must achieve.
Tips on Writing Design Input Requirements (DIR):
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Be specific and measurable: DIRs should be clear, specific, and measurable. This ensures that the engineering team can design and test the device to meet these requirements.
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Align with regulatory standards: Ensure that DIRs comply with relevant regulatory standards and guidelines. This is crucial for the approval and marketability of the medical device.
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Traceability: Maintain traceability between UNs and DIRs. Each DIR should be linked back to a specific user need to ensure that all user needs are addressed.
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Iterative review: Regularly review and update DIRs as the project progresses. This helps in accommodating any changes in user needs or regulatory requirements.
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GOT QUESTIONS?
FAQ about Design Input Requirements
Here are some answers to frequently asked questions about Design Input Requirements.
What is the difference between a User Need and a Design Input Requirement?
Why are DIRs important in medical device development?
Can DIRs change during the development process?
How detailed should DIRs be?
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