Medical PCB Assembly Services

Prototype and production PCB assembly with quick turnaround, IPC-certified quality, and full turnkey options

High-reliability Circuit Boards for Medical Devices

When lives are on the line, every trace, solder joint, and circuit layer matters.

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:

Leveraging Quality Across Industries

BESTProto is also AS9100D certified, an aerospace quality standard built on ISO 9001 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 for all leadless devices, such as BGAs, and hidden joints, with functional or in-circuit testing available on request. We verify every build before it ships, not just sample it.

Our Quality Guarantee

Turnaround & Service Options

Medical PCB assemblies typically ship in 5, 10, or 20 business days, with 24-hour rush service available on request. See the Quick-Turn PCB Assembly page for details on our turnaround times, full turnkey, partial turnkey, and kitted builds, 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.

Every build includes the documentation medical device programs depend on, including certificates of conformance, inspection records, and material certifications that 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?

While BESTProto is not currently ISO 13485 certified, we maintain ISO 9001:2015 and AS9100D certifications, demonstrating our commitment to quality management systems. We regularly work with ISO 13485-compliant medical device manufacturers, providing the traceability, documentation, and quality controls they require to support their FDA 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.

Can you help with FDA documentation requirements?

While we don’t provide regulatory consulting services, we provide comprehensive manufacturing documentation including certificates of conformance, material certifications, process records, and inspection reports that support FDA submissions and quality system requirements.

What is your typical lead time for medical device prototypes?

Our typical prototype lead times range between 5 and 20 business days after component procurement. Rush services may be available depending on current capacity and design complexity. Complex designs requiring special processes may require additional time.

Do you source components or do I need to supply them?

We offer flexible options. We can source components through authorized distributors (turnkey), you can supply all components (consigned), or we can provide a combination approach. We only purchase from franchise distributors 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.