Reliable Medical PCB Assembly
for Life-Saving Electronic Devices
Medical PCB assembly delivers the safety and reliability standards that modern medical devices demand, with certified quality management and full regulatory compliance. We provide medical PCBA solutions for implantable, diagnostic, and monitoring devices with fast turnaround times and flexible order quantities.
- Medical device PCB assembly with advanced HDI and flexible circuit capabilities
- Complete assembly services from fabrication through testing and documentation
- Fast 5-7 day turnaround with minimum order quantities of just 1 unit
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ISO9001 ISO13485
ISO14001
IATF
16949
IPC-A-610H International
Certification
Fully Automated
AOI Inspection
Medical PCB Assembly Services for Regulated Healthcare Applications
Medical PCB assembly requires IPC Class 3 build quality, ISO 13485-certified quality management, and full traceability of materials and processes from incoming inspection through final packaging.
At WellPCB, our medical PCB manufacturing workflow integrates Class 3 circuit board fabrication, microelectronics packaging, and FDA-aligned process control to meet stringent medical device requirements. Our advanced medical PCBA builds include HDI stackups with laser-drilled microvias, via-in-pad structures with epoxy sealing, 0.2 mm BGA pad pitch capabilities, and differential impedance tolerance of ±5 Ω.
Our precision assembly processes handle fine-pitch SMT components with 0.15 mm QFP spacing and ±30 μm placement accuracy. Each medical circuit board assembly integrates comprehensive process checkpoints such as solder joint integrity verification, AOI, solderability testing, micro-section analysis, and ionic contamination testing under NaCl equivalents below 1.56 μg/cm².
We maintain full documentation including reflow profiles, lot tracking, calibration logs, and nonconformance resolutions to support compliance with FDA 21 CFR Part 820, IPC-A-610 Class 3, and IEC 60601-1 standards. Our dual ISO 9001 and ISO 13485 certifications ensure consistent quality management across all medical PCB manufacturing processes.
Medical PCB assembly is evolving rapidly in response to rising device complexity, miniaturization, and regulatory enforcement across global markets. Our assembly solutions meet the highest standards of performance for electronic medical devices, including implantables and diagnostic systems, with complete lifecycle support from BOM sourcing through AOI and functional circuit testing.
Our Medical PCB Assembly Capabilities
We build HDI medical PCBs using laser-drilled microvias (Ø0.75 mm), stacked via structures, and sequential lamination cycles with dielectric thickness control to ±10%.
Supported stackups include 1+n+1 to 8+n+8, enabling high-speed routing with impedance tolerances of ±5 Ω.
These HDI PCB assemblies suit signal-critical systems such as pacemakers and neurostimulators.
| WellPCB Capability | Specification |
|---|---|
| Rigid PCB | 1–64 layers |
| Flexible PCB | 1–10 layers |
| Rigid-Flex PCB | 2–30 layers |
| Laser-Drilled Microvia Diameter | Ø0.75 mm (3 mil) |
| HDI Stackup Configurations | 1+n+1 to 8+n+8 |
| Impedance Tolerance | ±5 Ω (Single-ended ≤50 Ω) |
| Lamination Control | Dielectric thickness tolerance ±10% |
| Minimum Trace/Space | 1.8 mil / 1.8 mil |
| Aspect Ratio (Via) | Up to 40:1 |
| Via Types Supported | Blind, buried, via-in-pad, stacked vias |
| Common Use Cases | Pacemakers, neurostimulators, wearable ECG |
Our SMT platforms achieve 0.15 mm QFP spacing, 0.2 mm BGA pad pitch, and ±30 µm placement repeatability (3σ, Cpk ≥1).
We support medical PCBA integration of chip-scale packages (CSPs), CoB, and flip chip with underfill, plus epoxy-dispensed die attach with uniformity control below ±5 µm. Wire bonding is available for gold and aluminum.
We assemble flexible printed circuit boards using PI-based laminates (1 to 10 layers, thickness 0.05–0.8 mm) with overlay color matching and contour routing tolerances to ±0.1 mm.
Rigid-flex builds incorporate blind/buried vias, dynamic bend regions (<2 mm radius), and resin-padded interconnect zones for embedded medical equipment and surgical tooling.
We source and laminate Rogers RO4350B, RO3003, and RO3010; Taconic TLX and RF-35; and Arlon 85N.
These materials offer Dk values between 2.2 and 10.2 and Df as low as 0.0013, with z-axis CTEs under 40 ppm/°C and thermal conductivity from 0.20 to 0.95 W/m·K.
Material selection is guided by your specific frequency range, target impedance, and thermal loading profile.
WellPCB supports hybrid assembly using THT and SMT for components including transformers, shielded inductors, and connector systems.
Plated through-hole diameters from 0.3 mm with annular ring tolerances of ±75 µm. Joints meet Class 3 soldering requirements, verified by cross-section analysis and thermal shock testing from −40 °C to +125 °C.
We issue component-level traceability with BOM lot records, C of C, RoHS/REACH declarations, and serialized barcode labeling.
Quality documentation includes first article inspection, reflow profiles, AOI logs, ionic cleanliness test reports, and tool calibration records, aligning with ISO 13485, FDA QSR, and IEC 60601 mandates.
Each document type corresponds to a specific standard: IPC-A-610 for soldering, IPC-A-600 for board acceptability, ISO 13485 Clause 7.5.1 for process validation, and 21 CFR 820.30 for design controls.
2D and 3D AOI performed at 5 µm resolution verifies solder joint geometry, polarity, and orientation.
TDR (time-domain reflectometry) validates trace impedance for RF paths. Ionic contamination thresholds are controlled below 1.56 µg/cm² NaCl equivalent.
Additional tests include flying probe, micro-section, peel, and solderability testing per IPC-TM-650.
We support device PCB prototyping with MOQ = 1 and lead times from 3 to 5 working days, depending on assembly complexity.
Design for manufacturing (DFM) and design for assembly (DFA) reviews cover stencil aperture validation, thermal pad exposure checks, and test point optimization to reduce revision cycles.
Assembly is performed under controlled conditions for cleanroom compatibility.
Conformal coatings include parylene and silicone options for moisture protection and cytotoxicity compliance.
Substrates like RO3003, TMM10, and PTFE with low Dk (3.0–3.5) and Df (<0.002) support high-frequency medical applications such as imaging and telemetry systems.
Why Choose WellPCB for Your Medical PCB Assembly?
ISO 13485 and Class 3 Assembly for Medical Devices
Advanced SMT and Microelectronics Assembly
Controlled Impedance and Signal Testing Infrastructure
Flexible, Rigid, and Rigid-Flex Medical PCB Support
Cleanroom-Compatible Assembly Services and Testing
Integrated Fabrication and Assembly with Global Logistics
What are Medical PCBs?
Medical PCBs are printed circuit boards used in electronic medical devices where failure poses patient risk. These assemblies meet IPC Class 3 reliability standards and are built using high-Tg, low-loss laminates such as polyimide, Teflon, and RO3003 for thermal and electrical stability.
WellPCB fabricates medical PCBs with 1.8 mil trace widths, up to 28 oz copper, and dielectric control to ±10%. All medical PCBA builds include AOI, solderability testing, and ionic cleanliness control below 1.56 µg/cm² NaCl equivalent.
Our workflows are structured to align with FDA 21 CFR Part 820, which governs quality system regulation (QSR) for medical device manufacturing in the United States, and the standards maintained by the IPC (Association Connecting Electronics Industries), which defines global benchmarks for PCB design, performance, and assembly.
Applications range from wearable monitors to HDI neuromodulators, each requiring ISO 13485-compliant traceability, reflow documentation, and component lot tracking.
Common Applications of Medical PCBs​
Medical PCB assemblies are used across the full spectrum of diagnostic, therapeutic, and implantable technologies. Each application imposes strict electrical, thermal, and mechanical requirements that affect circuit board design, material selection, and assembly tolerances.
Implantable Devices
Diagnostic Imaging Equipment
Patient Monitoring and Wearables
Surgical and Robotic Tools
Laboratory Diagnostic Equipment
Design for Manufacturing Considerations
for Medical PCBs
Medical PCB design must account for manufacturing constraints, inspection access, sterilization compatibility, and material biocompatibility. These DFM practices reduce failure rates, simplify testing, and support FDA-compliant documentation throughout the medical device lifecycle.
| DFM Element | Medical-Specific Consideration |
|---|---|
| Component Spacing | Maintain ≥0.25 mm spacing for 0.5 mm pitch devices to ensure AOI and X-ray access. |
| Thermal Management | Use thermal vias and 2 to 3 oz copper in high-power areas to limit component temperature rise. |
| Sterilization Compatibility | Select materials compatible with autoclave (121 °C steam), ethylene oxide (EtO), or gamma sterilization, including polyimide, PTFE, and RO4350B substrates. |
| Inspection and Test Access | Include exposed test points, fiducials, and BGA escape routes to support ICT and TDR probes. |
| Biocompatibility and Coatings | Apply parylene or silicone conformal coatings for cytotoxicity compliance in implantable builds. |
| Via-in-Pad Structures | Plug, cap, and planarize vias in pad to prevent voids under CSP and QFN devices. |
| Traceability Features | Add silkscreen fields for serial numbers, lot codes, and barcode tracking linked to QMS logs. |
| Moisture and Ionic Protection | Implement dry-pack sealing, conformal coating, and ionic residue control below 1.56 µg/cm². |
How to Order Your Medical
PCB Assembly in 5 Easy Steps
Submit Your PCB Design
Upload your Gerber files or use our easy online PCB design tool to create your board layout. Make sure your files are complete and correctly formatted to ensure smooth processing and production accuracy.
Select Your PCB Specifications
Customize your order by choosing the technical specifications—number of layers, board dimensions, thickness, copper weight, solder mask color, surface finish, and more. Our intuitive interface helps you configure everything based on your project’s needs.
Get an Instant Quote
Once your design and specs are in place, you'll receive a transparent, instant quote. Pricing updates in real time as you modify options, so you can adjust your selections to match your budget before placing the order.
Confirm Order & Make Payment
Review your entire order for accuracy, including file previews and selected specs. After confirmation, proceed to secure checkout and choose your preferred payment method. You’ll receive an email confirmation with order details.
Production & Delivery
Your PCB moves into production immediately. We’ll keep you updated throughout the manufacturing process. Once completed, your boards are carefully packed and shipped to your door, with tracking information provided for your convenience.
WellPCB is trusted by millions of
businesses and innovators.
Why Choose WellPCB?
WellPCB stands out among USA PCB manufacturers by delivering superior quality, advanced solutions, and unmatched reliability. With years of experience serving global markets, WellPCB has earned a reputation as one of the top PCB manufacturers in USA.
WellPCB specializes in multilayer PCBs for advanced electronic applications. You can order these boards with $100 off using our special offer, providing high complexity at competitive rates for demanding projects.
Hommer Zhao
Founder and Chief Editor – Hommer Zhao
Welcome! I’m Hommer Zhao, the founder and Chief Editor of WellPCB. With years of experience in the PCB industry, I’m committed to making sure our content is both accurate and helpful. We’re proud to serve a growing community of over 4,000 customers worldwide, and our goal is to provide you with the best resources and support. Your satisfaction is our top priority, and we’re here to help you every step of the way!
Jesse Holland
Technical Manager – Jesse Holland
Hi, I’m Jesse Holland, an Engineer and Technical Manager at WellPCB. With years of experience in PCB design and engineering, I’m here to ensure that every project we work on meets the highest technical standards. I lead our team, focusing on precision and innovation, collaborating closely with clients to provide tailored solutions and expert guidance. Whether you’re facing a complex design challenge or need advice on technical aspects, I’m here to ensure your project is a success from start to finish.
Nathan Jensen
Purchasing Manager – Nathan Jensen
Hi, I’m Nathan Jenson, the Purchasing Manager at WellPCB. I’m responsible for sourcing the best materials and components to ensure our products meet the highest quality standards. With my extensive experience in procurement, I work closely with suppliers to secure reliable and cost-effective solutions while maintaining strong relationships to support our operations. I aim to ensure every project runs smoothly by providing the resources needed to deliver on time and to your satisfaction.
Emma
Sales Manager – Emma
Hey, I am Emma, sales manager at WellPCB. I studied electronic science and technology at university and have served customers for PCB and PCB Assembly service for several years.

I enjoy communicating with customers and our technicians to solve problems, and customers always say, "It's great to have you onboard".

It is my pleasure and honour to be helpful. Contact me now, and you'll know.
Bella and Cassiel
Sales Representatives – Bella and Cassiel
We’re Bella and Cassiel, your dedicated sales representatives at WellPCB. With our extensive knowledge of the PCB industry, we’re here to provide exceptional service and support. We take the time to understand your unique needs and are always ready to offer tailored solutions and advice. Whether you need product recommendations, assistance with your orders, or simply have a question, we’re here to ensure your experience is smooth and seamless at every step.
Mandy and Wendy
Sales Representatives – Mandy and Wendy
We’re Mandy and Wendy, your friendly sales representatives at WellPCB. Passionate about helping our customers, we bring a wealth of experience in the PCB industry to provide you with the best solutions and service. We take pride in building strong relationships with our clients, understanding their specific needs, and offering personalised support to ensure their satisfaction. Whether you’re looking for advice, product information, or assistance with any part of your order, we’re here to make your experience as smooth and efficient as possible.
Our Team
Our skilled engineers and technicians bring expertise and precision to every PCB assembly project. Committed to quality, efficiency, and innovation, our team ensures every order meets the highest UL, IPC, ROHS & REACH standards, delivering reliable solutions tailored to your needs.
- Founder and Chief Editor – Hommer Zhao
- Technical Manager – Jesse Holland
- Purchasing Manager – Nathan Jensen
- Sales Manager – Emma
- Sales Representatives – Bella and Cassiel
- Sales Representatives – Mandy and Wendy
Medical PCB Assembly Case Studies
PCB Manufacturing
This 6-layer high-reliability PCB is developed for medical electronic equipment where precision, reliability, and safety are paramount. Featuring gold finger connectors, bevel processing, and fine-pitch line control, it is ideal for use in critical medical interfaces and control units.
Technical Specifications:
- Layer Count: 6 layers
- Material: FR4 TG170
- Board Thickness: 1.6 mm
- Surface Finish: ENIG (Chemical Gold) + Gold Finger
- Minimum Line Width/Spacing: 5/5 mil
- Minimum Hole Diameter: 0.25 mm
- Special Features: Gold finger, Bevel edge
- Application: Medical Devices, Diagnostic Equipment
PCB Manufacturing
This flex-rigid PCB is specifically designed for medical treatment equipment, combining the flexibility of PI substrates with the robustness of high-TG FR4. Featuring ENIG surface finish, ultra-fine line/space, and high-precision alignment, it supports compact, reliable, and high-performance medical applications.
Technical Specifications:
- Application: Medical instruments
- Material: FR-4 + High-TG + Dupont Adhesiveless PI
- Structure: Rigid-flex combination
- Surface Treatment: ENIG (Electroless Nickel Immersion Gold)
- Line Width / Line Space: 5 mil / 3.5 mil
- Key Processes: Small slotting, coverlay lamination, base material machining, high precision alignment
- Technology Highlight: Multi-material bonding and flex-rigid transition integrity
PCB Manufacturing
This flexible circuit board is developed specifically for medical diagnostic and therapeutic equipment. Utilizing low-loss dielectric materials and fine line spacing, it is optimized for high signal integrity and extreme mechanical flexibility, enabling integration into compact, dynamic medical devices.
Technical Specifications:
- Material Structure: Double-sided adhesive + low-loss yellow coverlay + (Cu + glue + HF PI + glue + Cu) + coverlay
- Flexibility: Supports free bending and twisting
- Dimensional Tolerance: ±0.03 mm
- Board Thickness: 0.15 mm
- Reinforcement: 0.15 mm steel reinforcement (front and back)
- Surface Finish: Immersion gold (1–2 μ")
- Line Width / Spacing: 0.06 mm / 0.09 mm
- Manufacturing Processes: Solder coating, plug plating, coverlay lamination, film coating, shielding
- Application: Medical diagnostics, wearable sensors, microcontrollers
Client Feedback On Our Medical PCB Assembly
As an R&D manager, I have had an outstanding experience working with WELL-PCB. For many years, our company has entrusted them with the production, assembly, and programming of the boards developed in our R&D unit, and they have consistently exceeded our expectations.
Hamid Reza Moshayedi
R&D Manager
Their work is very impressively perfect. Today, when they check our company PCB board after assemble. They found a fake short point which many engineers has never found in the past years. But that is just designed so. The PCB board quality is excellent. Their service is also excellent.
MikeZ
My friend introduced WellPCB to me, the first try, a little look forward to. I ordered a 47*72 10ps PCB, and I can’t wait to receive my PCB. So I used expedited service and received my PCB in three days. I tested and soldered the PCB, Quality is really good, silkscreen, plating also great.
Warren Cliton
Medical PCB Assembly FAQs
What compliance standards do your medical PCBs meet?
WellPCB builds medical PCBs under ISO 13485:2016 and ISO 9001-certified systems. All assemblies comply with IPC-A-610 Class 3, IPC-6012 for rigid boards, and FDA 21 CFR Part 820 quality management. We support documentation, including first article inspection, ionic contamination logs, and reflow profiles.
Do you support microelectronics assembly for implantable medical devices?
Yes, our medical PCBA lines support CoB, flip chip, and epoxy die attach with ±5 µm placement accuracy. We assemble CSPs, BGAs, and 01005 components with underfill and encapsulation for implantable electronic medical devices requiring ultra-compact and robust circuit assemblies.
What testing processes are included for medical PCB assemblies?
Each board undergoes AOI, solderability testing, TDR for impedance verification, and optional flying probe or in-circuit testing. We also perform ionic contamination testing to confirm surface cleanliness under 1.56 µg/cm² NaCl equivalent, meeting medical device manufacturing cleanliness thresholds.
Can you provide materials suitable for sterilization and biocompatibility?
We offer laminates like polyimide, Teflon, and Rogers RO3003, as well as parylene and silicone coatings. These materials are suitable for devices exposed to autoclave, EtO gas, or gamma sterilization, and are compliant with medical industry biocompatibility and reliability standards. Replacing components in approved medical devices often requires new validation cycles or FDA notifications, creating significant qualification bottlenecks.
What is the minimum order quantity for medical PCB assembly?
Our medical PCB manufacturing services support rapid prototyping with a minimum order quantity of one unit. Lead times for low-volume device PCB assembly range from 3 to 5 working days, depending on design complexity and required documentation.
Get $100 Off Your First Medical PCB Assembly Order!
WellPCB provides Class 3 certified medical PCB assembly with full traceability, rapid prototyping, and ISO 13485-compliant process control for implantables, diagnostics, and high-performance medical equipment.
