Printed circuit board (PCB) assembly for medical devices requires expertise in specialized processes, stringent quality control, and regulatory compliance. Selecting the right manufacturing partner is crucial for bringing innovative, life-saving medical technologies to market. This article explores the top 10 PCB assembly companies worldwide that specialize in medical devices and equipment. We examine their technical capabilities, certifications, and experience servicing the medical industry.
Top 10 Medical Device PCB Assembly Manufacturers
1. RayMing Technology
RayMing is the leading medical device PCB assembly manufacturer worldwide. With over 15 years of experience manufacturing for medical OEMs, RayMing provides full system assembly for diagnostic imaging equipment, patient monitors, analyzers, probes, wearables, implants, and other electronic medical devices.
RayMing’s medical PCB capabilities include:
- Complex multilayer and HDI PCBs
- Fine pitch components down to 0201
- BGA, QFN, CSP and leadless packages
- Coating, potting and encapsulation
- Validated cleaning processes
- Full box build and unit integration
- Regulatory compliance – ISO 13485
RayMing maintains certified cleanrooms (ISO Class 6 and 7) and utilizes advanced inspection systems including 3D AOI and X-ray to ensure quality and reliability. Their medical manufacturing experts can take projects seamlessly from design to full scale production.
2. Jabil
Jabil is a global Fortune 500 contract manufacturer that provides turnkey solutions for medical OEMs. Their specialized medical facilities are FDA registered and ISO 13485 certified.
Key medical PCB assembly capabilities include:
- Complex PCBs, flex/rigid-flex boards
- Multi-axis advanced SMT systems
- Automated optical inspection (AOI)
- X-ray and functional testing
- Cleanroom assembly and packaging
- Supply chain services and new product introduction
Jabil supports medical customers with debugging, test development, process optimization, and volume manufacturing globally. Their scale, experience, and automation produce quality outcomes.
3. Flex
Flex is a large global electronics manufacturing services provider focused on medical, automotive, and aerospace/defense industries. For medical, they provide PCB assembly, full product engineering, testing, and supply chain services.
Their capabilities for medical PCB assembly include:
- High mix, low to mid volume production
- SMT assembly down to 0201 components
- Automated inspection and X-ray
- Validated cleaning processes
- Conformal coating, potting and encapsulation
- Packaging, sterilization, distribution
- ISO 13485 and FDA registration
Flex has an extensive track record assembling PCBs for patient monitoring, diagnostics, analyzers, sequencing, implants, and other medical applications meeting stringent quality and regulatory requirements.
4. LaBarge
LaBarge is a full-service contract manufacturer focused on high-reliability medical, aerospace, and defense applications. They provide complex PCB assembly along with box build integration and testing for medical OEMs.
LaBarge’s medical PCB assembly capabilities include:
- Prototyping through high volume production
- Advanced SMT assembly and component traceability
- Automated optical and X-ray inspection
- Conformal coating and potting
- Environmental stress screening
- Full system integration and test
- ISO 13485 and FDA registration
LaBarge has depth of experience manufacturing PCB assemblies for medical imaging, digital health, diagnostics, analyzers, and surgical equipment.
5. Saline Lectronics
Saline Lectronics provides electronics manufacturing and engineering services for OEM medical device companies. Located in Michigan, they specialize in assembling PCBs for high volume, life-critical applications meeting stringent quality and reliability requirements.
Their medical PCB capabilities include:
- High mix, medium to high volume production
- 01005 component assembly
- Automated inspection and X-ray
- Validated cleaning processes
- Packaging, sterilization, distribution
- Engineering collaboration and DFM
- ISO 13485, FDA registered
Saline has particular expertise manufacturing PCB assemblies for high volume disposable medical devices and diagnostic equipment.
6. SigmaTron
SigmaTron provides full system integration including PCB assemblies for medical OEMs from prototyping through high volume production. Their capabilities include:
- Flexible and rigid PCB assembly
- Fine pitch component assembly
- Conformal coating and potting
- Environmental stress screening
- Functional, ICT and burn-in testing
- Box builds and battery pack assembly
- ISO 13485 and FDA registration
SigmaTron supports startups and leading medical device companies across various therapeutic segments.
7. Sanmina
Sanmina is a large EMS company providing complete product lifecycle services from design to distribution. Their medical expertise includes PCB and box build assembly for OEM medical devices.
Key medical PCB assembly capabilities:
- High volume manufacturing globally
- Advanced SMT assembly down to 0201 components
- Automated optical inspection
- Cleanroom assembly and packaging
- Regulatory expertise – ISO 13485, FDA
- New product introduction and engineering
Sanmina supports the major medical device segments including imaging, IV pumps, oxygenators, analyzers, monitors, and more. Their scale facilitates high volume production and global regulatory compliance.
8. Creation Technologies
Creation Technologies is a full-service global EMS company focused on low to medium volume, high mix complex PCB assembly. Their services cater to the needs of medical OEMs and emerging companies.
Medical PCB assembly capabilities include:
- Prototyping to low volume production
- 01005 component assembly
- Conformal coating and potting
- Validated cleaning processes
- Product testing and inspection
- Supply chain and materials management
- ISO 13485 and FDA registration
Creation Technologies leverages automation, inspection, and quality processes tailored for lower volume complex PCBs to meet medical device requirements.
9. Key Tronic
Key Tronic manufactures PCB assemblies, box builds, and provides engineering services for medical OEMs. Located in the US, they specialize in FDA, ISO 13485 regulated programs for life-critical medical applications.
Capabilities include:
- Medium to high volume PCB assembly
- SMT assembly down to 0201 packages
- Automated optical inspection
- Environmental stress screening
- Functional test system design
- Supply chain and materials management
- Engineering collaboration and NPI
Key Tronic supports various medical segments including diagnostics, patient monitoring, and clinical analysis with quality focused manufacturing.
10. Nortech Systems
Nortech Systems provides electronics manufacturing and engineering services for medical device OEMs. They focus on low to medium complexity PCB assemblies for cost sensitive, high volume segments.
Their medical PCB assembly capabilities include:
- High mix, medium to high volume production
- Conformal coating and potting options
- Testing and inspection services
- Supply chain optimization
- Manufacturing engineering and support
- ISO 13485 and FDA registered
Nortech Systems enables medical customers to scale efficiently while maintaining stringent quality standards.
Medical PCB Assembly Challenges
Medical device PCB manufacturing presents unique challenges. Here are some key considerations when selecting a medical PCB assembly partner:
- Component Miniaturization – Medical devices trend toward miniaturization. PCB assembly using 0201 or smaller micro components is increasingly common. Manufacturers need precision placement and inspection.
- Cleanliness – Many assemblies require cleanroom conditions, validated cleaning processes, and tight controls on foreign materials to maintain purity.
- Quality – PCBs for life-critical devices demand near perfect reliability. Automated optical inspection, X-ray, testing and process controls are a must.
- Compliance – Strict regulatory requirements including ISO 13485, CMDCAS, and FDA registration apply. Full traceability on materials and validated processes are essential.
Selecting manufacturers with demonstrated experience navigating these complexities is crucial to releasing safe, effective medical devices.
Selecting a Medical PCB Assembly Partner
Here are key factors medical OEMs should consider when selecting a PCB assembly manufacturer:
- Technical capabilities – Assess their competency in key processes like SMT assembly, coating, testing. Micro component skills are a plus.
Quality approach – Look for automated inspection, well-developed testing, strong process controls and corrective action rigor. ISO 13485 is ideal. - Regulatory experience – Seek deep expertise navigating medical regulatory environments globally. FDA registration is a minimum.
- Medical focus – Choose companies with experience in applicable device segments that understand medical product development cycles.
- Services – Seek partners offering complementary services like prototyping, test development, box build, and distribution if needed.
- Quality culture – Ensure quality practices are ingrained not just mandated. Site visits to audit manufacturing are very valuable.
Selecting the right partner minimizes program risks and speeds time to market for medical devices.
KPIs for Medical PCB Assembly Manufacturers
Key metrics provide valuable insights into capabilities when evaluating medical PCB assembly manufacturers:
| Assembly Parameter | World Class Benchmark |
|---|---|
| On-time delivery | >98% |
| First pass yield | >98% |
| Customer rejects (PPM) | <100 PPM |
| Quality returns | <50 PPM |
| Process capabilities (Cpk) | >1.33 |
| Test coverage | 100% at board level |
| Cycle time reduction | 10% per year |
Top performing medical manufacturers will surpass these benchmarks. The best enable collaborative partnerships for quality and speed.
Conclusion
This overview of the top medical PCB assembly manufacturers worldwide provides key insights to assist medical OEMs with identifying the right outsourcing partner. Look for combined expertise in complex assemblies, stringent quality, regulatory excellence, and medical focus when making this critical decision. Partnering with a proven medical PCB assembly leader ensures delivering life-changing medical technologies efficiently, reliably, and safely.
Frequently Asked Questions
What are some examples of medical devices using complex PCB assemblies?
Some examples include:
- Imaging equipment like MRI, CT, and ultrasound
- Patient monitors and wearable sensors
- Clinical diagnostic equipment
- Surgical tools with electronic components
- Drug delivery devices like insulin pumps & infusion systems
- Therapeutic devices like defibrillators and neurostimulators
- Endoscopy pill cameras and probes
- Lab automation equipment
What PCB assembly services should medical OEMs look for?
Key assembly services medical OEMs should look for include:
- High-mix low to medium volume manufacturing
- Advanced SMT assembly of micro components
- Automated optical and X-ray inspection
- Validated cleaning processes
- Conformal coating, potting and encapsulation
- Functional, environmental and reliability testing
- Product engineering collaboration
- Regulatory expertise and compliance
What are important factors driving quality and reliability for medical PCB assemblies?
Critical factors include:
- Stringent process controls and corrective action rigor
- Extensive inspection using AOI and X-ray
- Comprehensive testing strategies (ICT, functional, environmental)
- Traceability and lot control through production
- Qualified components from approved suppliers
- Validation of manufacturing processes
- Configuration control over documents, software, tooling
- Focus on continuous improvement
How can medical OEMs evaluate PCB assembly partners?
Recommended practices for evaluating include:
- Reviewing their certification credentials – ISO13485, FDA registration
- Auditing their manufacturing facilities in person
- Assessing examples of their medical programs
- Reviewing quality metrics like yields, defects, customer feedback
- Running an audit builds of initial production
- Interviewing engineering and quality teams
- Vetting their supply chain processes
Why does regulatory compliance matter for medical PCB assembly?
Stringent regulation applies to medical device manufacturing to ensure safety and effectiveness. Key regulations include:
- FDA 21 CFR 820 – Quality System Requirements in US
- ISO 13485 – International standard for medical quality systems
- MDSAP – Medical Device Single Audit Program
- CMDCAS – Canada’s medical device conformity program
Compliance is mandatory. Selecting certified partners with regulatory expertise is vital to successfully navigating audits and approval processes when bringing medical devices to market.