This Design Control Verification & Validation Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines requirements for verifying design outputs and validating final products to ensure they meet user needs, intended use, and regulatory expectations. Digital delivery within 24 business hours.
This procedure outlines the processes for planning, executing, documenting, and approving design verification and validation activities. It covers test protocols, acceptance criteria, traceability, sample selection, reporting, and management review requirements. Delivered in editable Word format for easy customization. Consultancy support is available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are available for an additional fee.