MedPCB offers low-volume PCB assembly services compliant with the ISO 13485 standard, suitable for medical prototypes, trial production, and small-batch manufacturing.
• ISO 13485, RoHS, and IPC-A-610 Class 2/3 compliant.
• Fast-Turn, Expedited Services and Pilot Builds
• Full Traceability and Quality Documentation
• Flexible Orders, No MOQ.
Medical low-volume PCB assembly is the small-scale production of specialized medical circuit boards, usually ranging from a few dozen to a few thousand units. It relies on flexible manufacturing setups and precise assembly techniques to ensure high accuracy without requiring massive factory runs. This service supports medical devices in their early development, testing, or specialized low-market-demand stages. It helps lower upfront costs, allows rapid design changes, and delivers high-reliability boards before committing to mass production.
Every medical PCB is manufactured under an ISO 13485 certified quality management system. Controlled processes, documented procedures, and thorough inspections help ensure reliable and consistent production.
Start with as few as one board. Fast lead times support prototype validation, engineering samples, pilot production, early-stage medical device development and low-volume manufacturing without minimum order restrictions.
Receive complete manufacturing support from DFM review and component sourcing through PCB assembly, box build, and final system integration. Every low-volume project follows the same controlled manufacturing processes used for production-scale builds.
Our engineering team reviews every BOM for component lifecycle status, availability, approved alternates, and sourcing risks. We purchase component from authorized distributors to reduce counterfeit risks while maintaining full material traceability for medical projects.
Each production batch undergoes AOI, AXI, ICT, functional testing, and a final visual inspection as required. Our MES system records component traceability, inspection data, and production history to support your medical quality documentation and regulatory audits.
| Order Quantity | No minimum order quantity. Production starts from a single board. | |
|
Supports SMT, through-hole (THT/DIP), and mixed-technology PCB assembly. | |
| Supported PCB Types | Assembles rigid, flex, rigid-flex, and aluminum (metal core) PCBs. | |
| Board Size | Supports board sizes from 50 × 50 mm up to 1500 × 500 mm. | |
| Component Capability | Places components from 01005 packages to 0.2 mm fine-pitch BGAs, with no maximum component size limit. | |
| Placement Accuracy | Automated component placement accuracy up to ±0.035 mm. | |
| Component Sourcing | Offers turnkey, partial turnkey, and consigned assembly with access to 300,000+ genuine components. | |
| Surface Finish Compatibility | Compatible with HASL, Lead-Free HASL, ENIG, and OSP finished PCBs. | |
| Engineering Support | Includes free DFM, DFA, and DFT reviews before production. | |
| Quality Control | Built to IPC-A-610 Class 2 and Class 3 standards with AOI, X-ray inspection, and visual inspection. | |
| Lead Time | Standard production in 3–4 days, with expedited service available for urgent orders. |
Every component and bare PCB is inspected before production begins. Material verification helps ensure the correct parts are used and supports reliable performance in medical applications.
Medical PCBs are inspected throughout the assembly process to detect defects early and maintain consistent manufacturing quality.
• SPI (Solder Paste Inspection) – Verifies solder paste volume, position, and coverage before component placement.
• AOI (Automated Optical Inspection) – Detects missing, misaligned, incorrect, or poorly soldered components.
• AXI (Automated X-Ray Inspection) – Examines hidden solder joints on BGA, QFN, and other high-density medical PCB assemblies.
Each medical PCB is tested according to your product requirements to verify electrical performance and functionality.
• ICT (In-Circuit Testing) – Checks electrical connections and identifies shorts, opens, and incorrect component values.
• FCT (Functional Circuit Testing) – Confirms the assembled PCB operates as intended under normal operating conditions.
• Customized Testing – Performs application-specific testing based on your medical device requirements.
Every production batch is supported by complete manufacturing records, including material information, inspection results, and test reports. Full traceability helps support regulatory compliance and simplifies quality audits of medical PCBAs.
MedPCB helps reduce medical low-volume PCB assembly costs by improving manufacturability before production begins. Every project undergoes a DFM review to identify potential issues early, reducing rework and production delays.
Component selection also plays a key role in controlling costs. MedPCB reviews your BOM to recommend readily available components, reduce unnecessary part variations, and help prevent sourcing delays without affecting product reliability.
PCB layout and panelization are also optimized to improve assembly efficiency. Proper panel design allows multiple boards to be processed together, increasing production efficiency and lowering the cost per board while maintaining the quality standards required for medical devices.
Submit your Gerber files and BOM to us, and we will deliver a free DFA/DFM review alongside a competitive quote.
PCB assembly for robotic surgery control units that manage motor drives, force feedback, and precision movement. Built with fine-pitch SMT components and tested to ensure accurate, reliable operation in advanced surgical systems.
PCB assembly for ultrasound imaging systems, including beamformer boards, signal processing modules, and display control boards. Supports complex multilayer PCBs, high-speed circuits, and precision assembly for clear, reliable imaging performance.
Low-volume PCB assembly for implantable cardiac monitors that continuously record heart activity for long-term diagnosis. Supports ultra-miniature PCB designs, low-power electronics, and high-reliability manufacturing for pre-clinical development and engineering validation.
Low-volume PCB assembly for Holter monitors used to record continuous ECG data over extended periods. Designed for compact, wearable devices with stable signal acquisition, low power consumption, and dependable wireless connectivity.
Our Medical Low Volume PCB Assembly FAQ addresses essential questions regarding your manufacturing requirements. We cover our capabilities for complex medical electronics, supply chain management, assembly timelines, rigorous quality inspection protocols, and our capacity to scale from initial builds to production batches. For every medical device project, we guarantee precision-focused, medical-grade assembly standards.
No MOQ
+/-0.035mm
01005 (0.4mm*0.2mm)
±0.035mm
01005 (0.4mm*0.2mm)
3 Million~4 Million Soldering Pad/day
Manual Soldering, Dual-Wave Soldering, Selective Soldering
Axial, Radial, SIP, DIP, Connectors, Relays, Transformers, Custom Heavy Parts
Rigid, Flex, Rigid-Flex, High-TG, Heavy Copper
English
French
German
Japanese
Korean
