Medical Devices PCB

PCB Solutions for
Medical Devices

From patient monitoring and diagnostic imaging to implantable devices and surgical robotics — high-reliability PCBs that meet the strictest biocompatibility and safety standards.

ISO 13485 Certified IPC Class 3 Biocompatible Materials FDA 21 CFR Ready
ISO 13485
Medical quality certified
IPC 3
Class 3 standard
0.1mm
Min laser via dia
98%
First-pass yield
ISO
13485 certified QMS
IPC 3
High-reliability build standard
8h
DFM review turnaround
0.1mm
Min laser via diameter
Applications

Where our PCBs are
used in medical devices

Patient safety depends on board reliability. We manufacture for the full spectrum of medical electronics.

01

Implantable Neurostimulators

Ultra-thin 8-layer polyimide flex circuits with ISO 10993 biocompatible materials and 0.5 mm bend radius power spinal cord stimulators and deep brain neurostimulator implants.

02

Diagnostic Imaging & MRI Systems

16-layer heavy copper boards with precision ±5% TDR-verified impedance control and low thermal resistance drive MRI gradient amplifiers and diagnostic imaging equipment.

03

Patient Monitoring Systems

Any-layer HDI boards with 2.5/2.5 mil trace/space and stacked microvias route dense sensor and display interfaces within the compact enclosures of patient monitors.

04

Wearable Health Patches & CGMs

Rigid-flex circuits with skin-contact ENIG finish and biocompatible solder mask enable IP67 sealing-compatible continuous glucose monitors and wearable health patches.

05

Life Support & Critical Care Equipment

IPC Class 3 multilayer boards on high-Tg FR4 (Tg 170–220°C) with full FAI documentation support ventilators, defibrillators and infusion pumps.

06

Surgical Navigation & Robotics

HDI multilayer boards with stacked microvias and controlled impedance route high-speed sensor and motor-control signals in surgical navigation and robotic-assisted systems.

07

In-Vitro Diagnostic Analyzers

Multilayer boards with ENIG/ENEPIG finish and full lot traceability meet the documentation requirements of laboratory and point-of-care in-vitro diagnostic analyzers.

08

Hearing Aids & Sound Processors

Miniature rigid-flex assemblies with 0.1 mm laser via diameter and any-layer HDI routing fit the extreme space constraints of digital hearing aid and sound processor electronics.

The Engineering Challenge

Why medical PCBs demand
an ISO 13485 certified supplier

Medical devices are implanted in or adjacent to the human body. Board failure is not an inconvenience — it can cost a patient's life.

01

Patient Safety — Zero Defect Tolerance

Any latent defect in a cardiac or neuro device PCB can lead to patient harm. IPC Class 3 build standards, 100% electrical test and microsection analysis are not optional — they are the baseline for any medical supplier.

IPC Class 3 · 100% e-test · microsection QC
02

Biocompatibility & Material Traceability

Implantable and skin-contact PCBs must use ISO 10993 biocompatible materials. Full material declarations and lot-level traceability are mandatory for FDA and CE submissions. Every material used must be documented and auditable.

ISO 10993 · full material DRL · lot traceability
03

Miniaturisation Without Compromise

Modern medical wearables and implantables demand board sizes and trace widths that push fabrication to its limits — while maintaining the same zero-defect standards as large-format clinical equipment. HDI and rigid-flex are the only viable technologies.

any-layer HDI · 2.5/2.5 mil · rigid-flex
Board Technologies

PCB technologies for
every medical application

From implantables to imaging systems — we match the right board technology to your clinical application.

Implantables · Wearables

Biocompatible Flexible PCB

Polyimide flex circuits using ISO 10993 verified materials for cochlear implants, neurostimulators and continuous health monitors. Bend radii as tight as 0.5 mm with dynamic flex capability.

PI / LCP substrate dynamic flex 0.5mm bend radius
Get a Quote →
Imaging · Monitoring

High-Density Interconnect (HDI)

Any-layer HDI boards for diagnostic imaging, patient monitors and surgical navigation systems. Minimum 2.5/2.5 mil trace/space with stacked microvias for maximum routing density in compact form factors.

any-layer HDI 2.5/2.5 mil stacked microvias
Get a Quote →
ICU · Life Support

High-Reliability Multilayer

IPC Class 3 multilayer boards on high-Tg FR4 for ventilators, defibrillators and infusion pumps. Full cross-section analysis and thermal cycling qualification on every production lot.

IPC Class 3 Tg 170–220°C full FAI report
Get a Quote →
Technical Specifications

Built to automotive
specification.

Every parameter below is verified against IATF 16949 and IPC-A-600 Class 3 requirements. Full test reports and material traceability ship with every order.

  • ISO 13485
    Medical quality system
  • IPC 3
    High-reliability build standard
  • 0.1mm
    Min laser via diameter
  • ±5%
    Impedance tolerance
Request Capability Sheet →
ParameterAutomotive GradeStatus
Layer Count2 – 30 layers, any-layer HDIAvailable
Min. Trace / Space2.5 / 2.5 milAvailable
IPC Build StandardClass 3 — high-reliability medical gradeAvailable
Surface FinishENIG / ENEPIG / Immersion Ag / OSPAvailable
Biocompatible MaterialsISO 10993 verified on requestAvailable
Controlled Impedance±5% tolerance, TDR verifiedAvailable
Lot TraceabilityFull lot + serial number levelAvailable
FAI DocumentationAS9102-aligned first article reportsAvailable
Cleanliness TestingIPC-TM-650 ion chromatographyAvailable
Quality & Compliance

Certified for the most demanding medical requirements.

Medical device manufacturers require suppliers with documented quality systems and complete material traceability. Our ISO 13485 QMS covers every stage, with full FAI and material declarations on every order.

ISO 13485 : 2016
Medical devices quality management system
ISO 9001 : 2015
Third-party audited quality management
IPC-A-600 Class 3
High-reliability build standard
RoHS / REACH
Full material declarations available

Testing & Inspection Methods

  • 100% Automated Optical Inspection (AOI)Every layer, every board
  • X-Ray Inspection — BGA & Microvia Integrity100% on Class 3 lots
  • 100% Electrical Test (Flying Probe)Open / short on all nets
  • Impedance Test — TDR Equipment±5% verified per lot
  • Microsection & Cross-section AnalysisVia integrity and plating thickness
  • Ion Chromatography — CleanlinessIPC-TM-650 ionic contamination
  • Thermal Cycling per IEC 60068On qualification and production lots
  • First Article Inspection (FAI) ReportsFull documentation for regulatory submission
Case Studies

Projects we've delivered

Real automotive PCB challenges — and how we solved them.

Implantables · Neurostimulator

Spinal Cord Stimulator PCB

Ultra-thin 8-layer polyimide flex circuit for a Class III neurostimulator. ISO 10993 materials, biocompatible ENIG finish, and 100% electrical test with full lot traceability.

8L
Layers
0.1mm
Laser via
Class III
FDA class
Outcome

Zero failures across 3 years of implant follow-up. Full material declaration package enabled FDA 510(k) submission without supplier queries.

Imaging · MRI Systems

MRI Gradient Amplifier Board

16-layer heavy copper board for an MRI gradient amplifier. Required precision impedance control, low thermal resistance and full IPC Class 3 documentation.

16L
Layers
4oz
Copper
IPC 3
Standard
Outcome

99% first-pass yield on 800-unit production run. Impedance variance well within ±5% spec. Zero RMA returns in 18-month production period.

Wearables · Remote Patient

Continuous Glucose Monitor PCB

Ultra-thin rigid-flex circuit for a CGM wearable patch. Skin-contact ENIG finish, biocompatible solder mask, IP67 sealing-compatible design.

0.3mm
Board thickness
IP67
Seal-compatible
0ppm
2 yr field
Outcome

Zero in-field failures over 2 years. Biocompatibility documentation accepted by EU Notified Body for CE marking on first review.

Why HanSphere

Why Tier-1 suppliers
choose us.

Automotive procurement teams need more than a PCB factory — they need a certified partner with documented processes, fast engineering response and the depth to solve problems before the production line.

ISO
13485 Certified QMS

Medical quality management as standard

Our ISO 13485 QMS is not a sales claim — it is a fully documented, third-party audited system covering every process from incoming materials to final shipment, with records available for your regulatory submission.

IPC 3
High-reliability build

Class 3 — no trade-offs, no exceptions

Every medical PCB we build defaults to IPC Class 3 inspection criteria. We don't offer a 'medical option' — it is simply how we work.

100%
Tested before shipment

Every board electrically tested and AOI inspected

No medical board leaves our facility without 100% flying probe electrical test and full AOI. X-ray is applied to all BGA and blind-via boards.

8h
DFM turnaround

Engineering review before production starts

Our medical PCB engineers review your Gerbers for DFM, impedance and material compatibility issues within 8 hours — resolving problems before they reach the clinical environment.

Get a Quote

Start your automotive
PCB project today.

Our medical devices PCB engineering team will review your design and return a full DFM report and quote within 8 working hours.

  • DFM review included with every enquiry
  • NDA signed on request — standard practice
  • IATF 16949 documentation available
  • Response within 8 working hours
  • No commitment required to get a quote
Request Medical PCB Quote All files encrypted · Max 80MB per upload · NDA available

Request a Quote

Fill in the details below and we'll get back to you shortly.

WhatsApp