Medical PCB Assembly
Traceable, high-reliability medical electronic assembly for device manufacturers — rigid flex circuits for medical devices, HDI boards and fine-pitch PCBA, from first prototype to low volume production under an ISO 13485 quality system.
A PCBA Partner That Understands Medical Device Risk
Medical PCBs fail differently from consumer boards: the costs include recalls, regulatory exposure and patient safety. Medical PCB manufacturing therefore depends less on speed alone and more on controlled processes, traceable components and evidence that survives an audit years after shipment.
We provide medical PCB assembly services across the device lifecycle — engineering prototypes, clinical-build small batches and low volume production — with DFM review, regulated-material options and complete inspection records for every order.
Medical Device PCBs We Build
Typical device categories supported by our fabrication and assembly lines.
Patient Monitoring
Vital-sign monitors, ECG/SpO₂ modules and bedside systems that demand continuous, failure-safe operation.
Diagnostics & Imaging
High-density control and sensor boards for analyzers, ultrasound and imaging peripherals.
Wearable & Portable Devices
Compact rigid-flex and HDI assemblies for wearables, portable monitors and ambulatory recorders.
Surgical & Therapeutic
Reliable control boards for surgical instruments, therapy equipment and precision delivery systems.
Drug Delivery & Pumps
Accurate, repeatable assemblies for infusion pumps, dosing mechanisms and medication devices.
Dental & Laboratory
Dental equipment, lab automation and instrumentation requiring stable, quiet electronics.
Rigid Flex Circuits for Medical Devices & HDI Expertise
Portable and wearable devices need boards that fold, survive repeated handling and pack dense electronics into small enclosures. Our medical PCB assembly capability spans rigid, flex and rigid-flex construction, HDI microvia technology and fine-pitch component placement.
| Capability | Detail |
|---|---|
| Board Technologies | Rigid, HDI, Flex and Rigid-Flex circuits for medical devices |
| HDI Construction | Laser microvias from 0.075 mm, Anylayer and blind/buried via structures |
| Fine-Pitch Assembly | 01005 components, 0.35 mm pitch BGA, QFN and LGA packages |
| Layer Count | 1–24 layers (rigid), rigid-flex up to 14 layers |
| Soldering | Nitrogen reflow, selective and hand soldering under controlled profiles |
| Inspection | SPI, AOI, X-Ray for hidden joints, flying probe and functional test |
| Materials | RoHS/REACH compliant laminates; leaded assembly available on request |
| Order Stages | Engineering prototypes, small batch and low volume production |
Traceability Through Every Step
Documentation is designed into the build, not reconstructed after it.
Incoming Material Control
Components and laminates are received against purchase records with supplier lot numbers and incoming inspection.
Process Records
Reflow profiles, stencil prints and assembly parameters are recorded per build for future reference.
Inspection Evidence
SPI, AOI and X-Ray results, together with electrical test reports, are retained with the order file.
Shipment Documentation
Boards ship with packing records; certificates of conformity, material declarations and test reports are available on request.
Why Medical Device Teams Work With Us
Medical-Grade Quality System
Assembly operates under an ISO 13485 aligned quality management system, with documented procedures and disciplined change control.
Medical-Focused DFM Review
Engineers review designs for high-reliability assembly — pad geometry, thermal relief, cleanliness and test access — before production.
Rigid-Flex & Miniaturization
Rigid flex circuits for medical devices, HDI microvia boards and fine-pitch assembly support compact, wearable form factors.
Prototype to Production Path
Start with a single prototype and scale to low volume production on the same lines, retaining consistent records throughout.
Need a medical device PCB assembly manufacturer that fits your quality agreement? Tell us your documentation, inspection and packaging requirements with the RFQ — our engineers will confirm feasibility in writing before production starts.
Medical PCB Assembly FAQ
Practical answers on certification, traceability and rigid-flex builds.
Our quality management system is certified to ISO 13485, alongside ISO 9001 and IATF 16949. We operate medical electronic assembly under documented processes with traceable materials and retained inspection records. Certificate copies and compliance documentation can be requested through our sales team.
We fabricate and assemble rigid-flex boards from 2 to 14 layers and flexible circuits from 1 to 8 layers, including HDI rigid-flex with laser microvias. These constructions are widely used in handheld instruments, wearables and devices where folding interconnects replace fragile wire harnesses.
Yes. Medical programs typically begin with engineering prototypes and clinical-build quantities. Our low volume PCB assembly service starts from one board and scales through small batch to low volume production without changing the process controls or documentation standards.
Each order links recorded incoming material lots, assembly process parameters, SPI/AOI/X-Ray results and electrical test reports to the shipment. On request we provide certificates of conformity, material declarations and inspection reports suitable for your device technical file.
Yes. RoHS/REACH compliant materials are standard, and we can supply material declarations and finish information for compliance review. Leaded (non-RoHS) assembly remains available for legacy or exempt medical applications — state the requirement on your BOM.
Every build receives solder paste inspection and automated optical inspection. BGA, QFN and other hidden-joint packages receive X-Ray inspection. Flying probe electrical test and functional test using customer-supplied procedures can be arranged.
Provide Gerber (RS-274X) or ODB++ files, a BOM with manufacturer part numbers and pick-and-place data. Note any regulatory, cleanliness or lead-free-exemption requirements up front so the quote reflects them from the first revision.
Send Us Your Medical PCB Project
Share your Gerber files, BOM and compliance requirements — receive a detailed medical PCB assembly quote within 24 hours.