ISO 13485 (Clause 7.3) - Design Input and Output Form Template

Maintain clear, traceable, and regulatory-compliant design documentation with our ISO 13485:2016 Clause 7.3 Design Input & Output Form Template. Design inputs define the functional, safety, and regulatory requirements for a medical device, while design outputs translate these requirements into product specifications, drawings, and test results. This structured form ensures proper documentation, traceability, and compliance with ISO 13485:2016, FDA 21 CFR Part 820.30, MDR, and IVDR.

✔ Pre-Formatted Design Input & Output Documentation Form – Aligned with ISO 13485:2016 Clause 7.3 requirements.

✔ Design Input Definition Section – Capture key functional, regulatory, and safety requirements.

✔ Design Output Documentation – Ensure outputs meet input requirements through traceability.

✔ Risk Management Integration – Link design elements with ISO 14971 risk management assessments.

✔ Verification & Validation Requirements – Document acceptance criteria and testing plans.

✔ Approval & Review Sections – Assign responsibility and maintain traceability.

✔ Editable Digital Format – Fully customizable for different medical device classifications and project phases.

This ready-to-use form is ideal for R&D teams, quality managers, and regulatory professionals, ensuring a structured, compliant, and audit-ready design development process.

Download the ISO 13485:2016 Design Input & Output Form Template today and enhance your design control process!