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Validation Manufacture

A technician wearing a white lab coat and safety gloves operates an electronic testing machine in a clean, modern manufacturing environment. The screen displays a detailed circuit board layout and diagnostic data. The technician holds a green printed circuit board (PCB) while typing on the machine’s integrated keyboard. Storage bins and electronic components are visible in the background, indicating an electronics testing or assembly facility.

Confirming Reproducibility and Compliance

The Validation Manufacture phase is the final step in G&H’s New Product Introduction (NPI) process. This critical stage verifies that every aspect of production - from materials and operators to equipment and documentation - consistently produces devices that meet specification and regulatory requirements.

By completing this validation under ISO 13485 and FDA 21 CFR 820, G&H confirms that the manufacturing process is fully reproducible, controlled, and ready for commercial release.

Controlled Validation Execution

Validation builds are carried out by trained Production Operators under defined conditions using approved tools, materials, and validated instructions. Unlike previous stages, Production Engineering and Subject Matter Experts may observe the process but cannot directly assist with builds, ensuring that results reflect true production capability.

Sampling rationale follows ISO 13485:2016 and statistical best practice - typically three independent test data points or a minimum of 30 devices - to demonstrate process performance and reproducibility.

Our Approach

  • Validation Master Plan (VMP) – defines sampling rationale, acceptance criteria, and required documentation.
  • Process Qualification (IQ/OQ/PQ) – installation, operational, and performance verification of production equipment and procedures.
  • Project Deviation Records – capturing and tracking any variances encountered during validation.
  • Formal Non-Conformance Reports – documenting deviations for audit traceability and resolution.
  • Final Documentation Integration – updating the Design Master Record (DMR) and Device History Record (DHR) with validated data.

All results are recorded, reviewed, and approved within G&H’s Quality Management System, ensuring audit readiness and long-term compliance.

Outcome and Benefits

  • Proven reproducibility and process control.
  • Fully validated manufacturing documentation and records.
  • Confidence to commence full-scale production.
  • Verified compliance with ISO 13485 and FDA 21 CFR 820 standards.
  • Establishes a compliant foundation for sustained commercial manufacture.

Through this structured validation process, G&H | ITL ensures that your medical device is not only manufacturable - but manufactured right, every time.

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