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Verification Manufacture

G&H engineer performing verification manufacturing, testing and calibrating electronic and photonics components on a production bench in a controlled manufacturing environment.

Confirming Process Stability and Repeatability

The Verification Manufacture stage is where G&H confirms that a medical device can be manufactured consistently, safely, and in full alignment with its validated design documentation. This phase demonstrates process control and build repeatability - critical prerequisites before entering full validation and commercial manufacture.

By verifying both product and process integrity at this stage, G&H ensures that scale-up occurs with complete confidence in performance, compliance, and quality.

Verification Build Execution

Verification manufacturing is conducted by Production Operators, supported by Production Engineering and customer Subject Matter Experts (SMEs). The process replicates real production conditions, using defined tooling, work instructions, and documentation to confirm consistency and traceability.

Sampling rationale follows accepted statistical guidelines - typically a minimum of three data points - to demonstrate process uniformity across critical build parameters.

Our Approach

  • Controlled Verification Builds – replicating full production using validated work instructions.
  • Data and Time Capture – recording operator performance, assembly time, and material usage to validate manufacturing metrics.
  • Verification Manufacture Record (VMR) – documenting all findings, including process deviations or documentation updates.
  • Deviation Management – handling exceptions in accordance with ITL's Non-Conforming Product procedures.
  • Cross-Team Support – engineers and SMEs available for build observation and troubleshooting without direct intervention.

Every element of the build - from operator training to part traceability - is reviewed and documented for audit readiness and validation continuity.

Outcome and Benefits

  • Proven process repeatability prior to validation.
  • Documented manufacturing data and performance benchmarks.
  • Verified alignment between design documentation and real-world build outcomes.
  • Reduced risk of rework or delays during validation.
  • Strengthened confidence in manufacturing reliability and quality control.

This stage confirms that your device, documentation, and processes are ready to enter full validation and regulatory submission.

Next Step: Validation Manufacture

G&H NPI Services