Medical PCB Assembly Services
High-reliability Circuit Boards for Medical Devices
At BESTProto, we build PCBs that power medical devices with the precision, compliance, and reliability required in clinical environments. Whether you’re developing diagnostic tools, wearable monitors, or therapeutic instruments, our medical PCB assembly services support your mission from prototype through production launch.
Quality Standards & Certifications
Medical devices are held to some of the highest quality and safety standards in electronics manufacturing. BESTProto builds to IPC-A-610 Class 2 and Class 3, the workmanship standard required for high-reliability and life-critical electronics, and backs that with:
- ISO 9001:2015 Certified: A documented quality management system covering every stage of assembly, from incoming inspection to final test.
- IPC J-STD-001 Certified: Consistent, reliable interconnections for mission-critical builds.
- ESD-controlled Assembly: Static-safe handling and workstations throughout the process.
Leveraging Quality Across Industries
BESTProto is AS9100:2016 certified, an aerospace quality standard built on ISO 9001:2015 with added requirements for risk management, configuration control, and first article inspection. We apply that same rigor across every industry we build for, including medical.
Every medical PCB assembly goes through Automated Optical Inspection (AOI), and X-ray inspection covers leadless devices such as BGAs and other hidden joints. Functional or in-circuit testing is available on request. We inspect every build before it ships rather than sampling.
Our Quality Guarantee
Turnaround & Service Options
Medical PCB assemblies follow our three turnaround tiers: Express, Expedited, and Standard, with turn times of up to 5, 10, and 20 business days, respectively. Each build ships as soon as it is complete. See the Quick-Turn PCB Assembly page for the full tier descriptions, turnkey and kitted options, and our assembly process outline.
Medical PCB Assembly Capabilities
We understand that your electronics must perform with utmost reliability. Our prototype-to-production model ensures every step of your design transition meets medical industry expectations for durability, scalability, and performance. At BESTProto, we support all major assembly types and related services, including:
- IPC Class 3 Surface Mount, Through-Hole, and Mixed Technology
- Circuit Board Assemblies with devices down to 01005 sizes
- Rigid, Flex, and Rigid-Flex PCB Assembly
- Lead-Free & Leaded (ROHS & Non-ROHS) Solder Options
- BGA, uBGA, LGA, CSP, QFN, and QFP Placement and Rework
- Conformal Coating (Acrylic, Silicone, Polyurethane)
- Automated Optical Inspection (AOI) and X-Ray Inspection
- Flying Probe, Functional and Environmental Stress Testing
- Component Traceability & Secure Supply Chain Control
Why Medical Device Teams Choose BESTProto
Medical device development moves fast, and a design change six weeks before a milestone shouldn’t mean starting your build from scratch. BESTProto’s process engineers work directly with your team through each design revision, catching manufacturability issues early and keeping your prototype-to-production timeline intact.
Medical PCB builds include the documentation that medical device programs depend on: certificates of conformance, material certifications, process records, and inspection reports. These records support your own quality system and regulatory submissions.
From prototype to production ramp, the same team stays on your project, so your quality expectations and design intent carry through every build.
Frequently Asked Questions
About Our Medical PCB Assembly Capabilities
Do you have ISO 13485 certification?
No. BESTProto is not currently certified to ISO 13485. We are certified to ISO 9001:2015 and AS9100:2016, and we regularly build for medical device manufacturers that operate under ISO 13485. We provide the traceability, documentation, and quality controls their quality systems require. The manufacturer remains responsible for its own regulatory submissions.
What quality class do you recommend for medical devices?
Most medical device applications benefit from IPC Class 2 or Class 3 assembly standards. Class 3 is recommended for life-sustaining or life-critical applications where failure is unacceptable. Our engineering team can help you determine the appropriate class for your specific application.
What manufacturing documentation do you provide for medical devices?
We provide manufacturing documentation, including certificates of conformance, material certifications, process records, and inspection reports, that supports your quality system and regulatory submissions. We do not provide regulatory consulting, and your team remains responsible for the content of its submissions.
Do you source components or do I need to supply them?
We offer flexible options. We can source components for you (turnkey), you can supply all components (consigned), or we can provide a combination approach. Every component purchase goes through a verified U.S. distributor to ensure authenticity and traceability.
Do you offer cleanroom assembly?
BESTProto does not currently operate a certified cleanroom environment. However, we maintain rigorous cleanliness protocols, ESD controls, and humidity absorption procedures suitable for most medical device applications.
Can you handle mixed technology assemblies?
Yes, we routinely assemble boards combining surface mount and through-hole components. Our flexible manufacturing process accommodates complex mixed-technology designs common in medical electronics.
Your Mission Deserves the BEST
Proudly Supporting Those Who Cure
Ready to move your medical device project forward with confidence?
Let BESTProto be your partner in delivering compliant, high-reliability PCB assemblies and Box Builds that meet or exceed medical regulatory expectations.
Contact Us Today