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Pre-manufacturing Checks

G&H team members conducting pre-manufacturing checks in a meeting room, reviewing technical documents and specifications around a conference table.

Ensuring Manufacturing Readiness and Compliance

Before any new medical device enters production, G&H conducts a series of Pre-Manufacturing Checks to verify that the design, documentation, and processes are ready for controlled manufacture.

This stage bridges product development and new product introduction (NPI), confirming that your device can be integrated seamlessly into our ISO 13485- and FDA 21 CFR 820-compliant quality system.

Comprehensive Documentation and Gap Review

Our New Product Introduction (NPI) team lead a structured Design Master Record (DMR) and manufacturing gap analysis, reviewing the supplied technical documentation against G&H’s Quality Management System and regulatory requirements. During this activity, we:

  • Review all supplied drawings, bills of materials (BOM), and assembly documentation.
  • Identify missing or inconsistent design files or specifications.
  • Confirm regulatory and quality documentation alignment.
  • Assess compatibility with G&H’s validated production processes and systems.

This early diligence ensures your device transitions into manufacturing efficiently, minimizing risks of non-conformance or delays later in the process.

Our Approach

  • DMR Gap Analysis – evaluating the completeness and structure of the Design Master Record.
  • Regulatory Alignment – verifying adherence to ISO 13485:2016 and FDA 21 CFR 820 Quality System Regulation.
  • Technical Package Review – ensuring all manufacturing documentation supports repeatable, controlled production.
  • Integration Readiness – confirming that your design can be executed within G&H’s systems and production infrastructure.

Every gap or risk identified is documented, reviewed with the customer, and resolved before the next NPI phase begins.

Outcome and Benefits

  • Reduced risk of non-conforming product during initial builds.
  • Full alignment between your technical file and G&H’s quality processes.
  • Faster transition to process validation and production readiness.
  • Confidence that your design will perform consistently under regulatory control.

By verifying every element before manufacturing begins, G&H ensures your device is built on a foundation of precision, compliance, and confidence.

Next Step: Process / Design Improvements

G&H NPI Services