Orthopedic Contract Manufacturing Solutions

RevZero manufactures complex, tight-tolerance orthopedic parts across implants, instruments, and supporting hardware. We commonly support:

• Implantable parts such as plates, screws, pins, and fixation components
• Precision-machined metal parts for surgical systems and instruments
• Molded polymer parts, including handles and interface components
• Tight-tolerance parts requiring advanced inspection and validation
• Parts requiring full traceability and documented process control

If you have prints available, we can quickly confirm manufacturability, identify critical features, define the inspection approach, and establish the most stable path from prototype to production.

RevZero approaches validation as part of a controlled machining and inspection process, not a one-time event. We align validation activities to your requirements and the risk profile of the part.

This typically includes:

• Documented process development and defined machining parameters
• First article inspection and capability confirmation
• Inspection plans tied to critical features and tolerances
• Support for IQ/OQ/PQ requirements when applicable
• Ongoing process control and full traceability

Our goal is to establish a stable, repeatable orthopedic parts manufacturing process that holds up from first articles through production, not just initial builds.

Timelines depend on part complexity, tooling approach, and validation scope — but we work quickly from quote to first article without skipping the steps needed to protect quality.

A typical injection molding program includes:

• DFM review + quote
• Tool design and build
• Sampling + first articles
• Validation execution (as required)
• Controlled transition to production

Once we review prints, volumes, and validation expectations, we provide a clear schedule for tooling, first article, and ramp-up.

Yes. RevZero supports orthopedic programs from early prototypes through full-scale production. We build programs with scalability in mind so prototypes aren’t treated as one-off parts, and production isn’t treated as a separate handoff. The same DFM logic, inspection discipline, and process control carry through each phase.

RevZero supports orthopedic OEM quality and regulatory requirements by maintaining controlled manufacturing documentation and traceability throughout the program. This typically includes:

• Inspection documentation tied to print requirements
• Material and lot traceability
• Process documentation and manufacturing records
• Support for customer audits through organized, consistent quality systems

We understand what orthopedic OEMs need to see during supplier qualification, ongoing performance reviews, and audit activity and will work with you to meet your specific documentation requirements.