In medical device manufacturing, the journey from engineering handoff to full-scale production requires precision, documentation, and strict regulatory alignment. Whether launching a new product or transferring an existing line, OEMs must ensure every process is validated, every material is traceable, and every part meets specification starting with the first article build.
At Sanbor Medical, that’s where our expertise begins. As an ISO 13485–certified and FDA-registered contract manufacturer, we support OEMs through this critical transition, turning approved designs into validated, compliant, and scalable production systems across our global facilities.
Our goal is to make each step — from first article approval through full-scale manufacturing — seamless, transparent, and audit-ready.
First Article Approval (FAA) is far more than a milestone; it’s the foundation of a controlled, repeatable manufacturing process. The first article build demonstrates that the production process, materials, and equipment meet the design intent and regulatory requirements defined by the OEM.
At Sanbor Medical, we treat the first article as the proof point of quality assurance. Each FAA includes:
Dimensional and functional verification of every critical feature
Material and component traceability for regulatory compliance
Process documentation and inspection data for validation records
Operator and equipment qualification to confirm repeatability
Once the OEM approves the first article, all validated parameters, inspection methods, and material controls become part of the ongoing production plan, ensuring the same standard of quality for every subsequent build.
Scaling a medical device for volume production requires discipline, especially when regulatory oversight is involved. Sanbor Medical manages this process through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to confirm that all processes consistently produce conforming products.
We work closely with OEM engineering and quality teams during each phase to align:
Manufacturing procedures and work instructions
Equipment calibration and process control limits
Supplier qualifications and material certifications
Cleanroom protocols, labeling, and packaging validation
This structured approach minimizes variability, accelerates approvals, and ensures consistent, compliant output across every production run. For OEMs, it means reduced risk, faster scale-up, and assured readiness for FDA or notified body audits.
Medical device quality isn’t negotiable. Every process at Sanbor Medical is governed by our Quality Management System (QMS) aligned with ISO 13485 and FDA 21 CFR Part 820.
Our dedicated quality and engineering teams oversee:
Device Master Record (DMR) and Device History File (DHF) management
Incoming and in-process inspection programs
CAPA and nonconformance tracking
Continuous improvement through internal audits and process review
This ensures that every component meets exacting medical-grade standards before shipment.
With facilities in the U.S. and lower cost countries, Sanbor Medical offers OEMs flexible, globally coordinated manufacturing capacity — while maintaining unified documentation and quality processes across all locations.
This multi-region footprint allows OEMs to:
Support regional product launches and market-specific compliance
Balance cost, logistics, and lead time
Reduce risk through dual qualification and validated process transfers
Each facility operates under the same QMS, ensuring that a first article approved in one region can be replicated exactly at another — with identical materials, documentation, and validation data.
In an era of evolving supply chain risks and regulatory scrutiny, this level of consistency gives OEMs the confidence to scale globally without compromising compliance or quality.
Many established OEMs turn to Sanbor Medical when transitioning mature product lines from internal facilities or less specialized suppliers. Our structured transfer process covers documentation migration, tooling verification, supplier requalification, and new first article approval — all under a single quality system.
We also provide sustaining engineering support to extend product lifecycles, optimize manufacturability, and implement controlled design changes without disrupting supply or regulatory approval.
Whether managing next-generation NPIs or legacy device transfers, our focus remains constant: predictable quality, cost control, and uninterrupted supply continuity.
Medical OEMs partner with Sanbor Medical not only for our technical capability, but for our commitment to transparency, communication, and regulatory alignment. From first article approval through steady-state production, every process is designed to meet your specifications, maintain compliance, and ensure long-term success.
Sanbor Medical helps OEMs move seamlessly from first article to full-scale production, delivering quality, consistency, and compliance at every step.
Contact Sanbor Medical to discuss your next project and learn how our integrated, ISO 13485–certified manufacturing solutions can help you achieve first-pass success and global scalability.
