When it comes to developing complex electromechanical medical devices, getting from concept to production requires more than just technical precision. It demands a partner with deep regulatory knowledge, proven manufacturing capabilities, and a commitment to quality.
For over 30 years, Sanbor Medical has served as a trusted contract manufacturing partner for leading OEMs, delivering reliable solutions for the medical industry. If you’re considering outsourcing your manufacturing, here’s what to expect and how Sanbor Medical supports you at every stage of the journey.
Outsourcing medical device manufacturing doesn’t mean handing over your designs and hoping for the best. In fact, the most successful partnerships begin with collaborative engineering support.
At Sanbor Medical, our teams work closely with OEMs during the early stages of the process to ensure a seamless handoff from prototype to production. This includes:
First Articles for approval
BOM review
Material sourcing recommendations
Process Failure Mode & Effects Analysis (PFMEA)
By engaging early, we help reduce avoidable costs, prevent downstream delays, and improve device performance and reliability.
In a regulated environment, compliance is the core to your success. Sanbor Medical’s operations are rooted in FDA-registered, ISO 13485-certified processes that ensure consistent quality and full traceability.
We support:
Document control and DHF compliance
Device history records (DHRs)
Process validation (IQ/OQ/PQ)
UL, CE, and RoHS compliance support
With a deep understanding of regulatory frameworks for Class II and III medical devices, Sanbor helps OEMs avoid costly rework and product holds.
Medical OEMs face ongoing pressure from global supply chain disruptions, raw material shortages, and pricing volatility. That’s why choosing a manufacturer with established, flexible sourcing channels is key.
Sanbor Medical leverages a global supply chain footprint, with factory locations in the U.S. and additional lower cost countries, to ensure:
Redundancy in component sourcing
Cost-effective procurement
Logistics flexibility to avoid bottlenecks
Whatever is needed for your project, our team ensures procurement aligns with your timeline and quality standards.
Once the foundation is in place, Sanbor Medical moves your project into scalable production using:
Lean manufacturing principles
Root cause CAPA processes
Continuous quality monitoring
With more than three decades of experience, Sanbor knows how to manage the intricate requirements of Class II and III medical devices.
Explore our manufacturing capabilities
Many contract manufacturers stop at subassemblies. Sanbor goes further, offering complete product box builds including:
Final mechanical/electromechanical assembly
Packaging support
Labeling to UDI and MDR requirements
Global logistics coordination
Testing
Programming
This end-to-end approach simplifies vendor management, shortens timelines, and ensures consistent quality all the way to the customer’s hands.
Outsourcing is only as successful as the partner you choose, and experience makes a difference.
Sanbor Medical brings:
30+ years of medical device manufacturing expertise
FDA-registered, ISO 13485-certified facilities
Dedicated project managers and engineering teams
A reputation for on-time delivery and transparent pricing
Our history is filled with long-term partnerships, not transactional relationships. Many of our clients have relied on us for over a decade to support them through product iterations, regulatory updates, and market expansion.
More about Sanbor Medical’s history and mission
Outsourcing medical device manufacturing isn't just a cost-saving measure. It's a strategic decision that can impact quality, compliance, and speed to market. With Sanbor Medical, you're choosing a partner who understands the stakes and brings decades of proven performance to the table.
Whether you're scaling production for an existing device or bringing a new innovation to life, we’ll support you at every stage, including concept to production and beyond.
Ready to start a conversation? Contact our team today