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Manufacturing Transfer
We qualify the process for commercial production. Documentation, tooling, and processes are formally validated so your device can be produced to specification, repeatably, under a controlled quality system.
Please feel out the form below and someone from our team will contact you shortly.
Phase Overview
Manufacturing Transfer is where a stable process becomes a validated one. Process documentation is finalized under change control, tooling and equipment are installed and qualified, and installation, operational, and performance qualification are executed to demonstrate the process consistently produces conforming devices. Operators are trained and certified against approved work instructions. The output is a validated production process with the documented evidence to support regulatory submission and the readiness to build commercially.
What Happens in This Phase
Each phase draws on a different combination of our disciplines and sub-disciplines. These are the ones that take a stable process and qualify it for commercial production.
Production Documentation
The device master record, work instructions, and inspection criteria finalized and released under change control.
Tooling & Equipment Qualification
Production tooling and equipment installed, commissioned, and dimensionally qualified against specification.
Process Validation
IQ, OQ, and PQ executed against approved protocols to demonstrate the process consistently produces conforming product.
Test Method Validation
Inspection and test methods validated, with measurement system analysis confirming the data can be relied on.
Supplier Qualification
Suppliers formally approved, agreements executed, and incoming inspection established for production supply.
Operator Training & Certification
Operators trained and certified against released work instructions, with training records completed.
Quality System Integration
The process brought under the quality system, with change control, nonconformance handling, and CAPA in place.
Process Risk Management
Process FMEA finalized, controls verified as effective, and residual risk documented against the validated process.
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What You Walk Away With
A validated production process ready to build commercially: a released device master record with approved work instructions, qualified tooling and equipment, executed IQ, OQ, and PQ documentation, validated test methods with measurement system analysis, approved suppliers with incoming inspection defined, certified operators with completed training records, and a finalized process risk file.
Why This Phase Matters
Validation is where the process becomes fixed. Once a process is validated, changing it means revalidating it, which is why the work of the prior phases matters so much here. Arriving with a capable, controlled process means validation documents what you already know to be true. Arriving without one means locking in a process that can't hold its specifications, and every correction afterward carries the cost of requalification.
Commercial Launch
With the process validated and production qualified, your device moves into Commercial Launch, where manufacturing begins supplying the market and performance is monitored against commercial demand.
Please feel out the form below and someone from our team will contact you shortly.
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