Description:

Translate user needs into technical, measurable design inputs to drive design control and verification for your medical device.
• Confirm Project Name and DHF Number to maintain design traceability.
• Replicate key project description details from the User Requirements form for consistency.
• Define design inputs as measurable technical requirements derived from user needs.
• Document applicable technical standards considered relevant to specifications.
• Capture evidence used to set specs (e.g., literature review, testing, user survey, device characterization).
• Build a summary table linking #UR to #DI, with acceptance criteria, Source of AC, and design verification method.

Your needs:

• medical device design inputs aligned with ISO 13485 requirements
• medical device design inputs for MDR decision-making
• Reduce rework by making verification-ready specs from day one.

This form is used once user requirements are stable enough to be converted into device specifications, and before design outputs are finalized, so verification can be planned and objective.

Key requirements covered include defining what design inputs are (technical requirements derived from user needs) and why design verification matters (proving outputs meet inputs with objective evidence).
• Ensure each DI is measurable and unambiguous with clear acceptance criteria.
• Maintain traceability by linking #UR to #DI.
• Record the Source of AC (bench data, literature, surveys, characterization).
• Specify the planned design verification method per DI.
• Document pre-design-control evidence (tests, surveys, benchmarks) supporting specs.

Within Lexqara, we help align design inputs with risk management, design support, verification planning, and audit readiness. Explore our Resource Center and our Design Control Support for Start-up Companies, and benchmark expectations via FDA Design Controls. Download the template or request a short gap assessment.

Used consistently, this form strengthens DHF coherence and speeds decisions by keeping specifications, evidence, and verification methods aligned as the project evolves.