Medical devices demand the highest level of precision, reliability, and regulatory compliance. Our medical-grade flexible PCBs are manufactured in ISO 13485 certified facilities with FDA registration, ensuring every circuit meets the stringent requirements of life-critical applications.
From miniaturized implantable devices to advanced diagnostic equipment, flexible circuits offer unique advantages in medical applications. Their ability to conform to anatomical shapes, withstand repeated sterilization cycles, and maintain reliable performance makes them essential for modern medical technology.
We understand that in medical applications, there is zero tolerance for failure. Our quality management system, combined with rigorous testing protocols and full traceability, ensures that every flex PCB we deliver is worthy of the trust you place in it.
Full regulatory compliance with documented quality management systems. We maintain FDA registration and ISO 13485 certification for medical device manufacturing.
USP Class VI compatible materials suitable for patient-contact applications. Our medical-grade polyimides and adhesives meet stringent biocompatibility requirements.
Class 100 cleanroom environment for contamination-free assembly. Critical for implantable devices and sterile medical equipment.
Complete lot traceability from raw materials to finished product. Every component, process step, and test result is documented and retrievable.
Flexible PCBs have become indispensable in modern medical technology, enabling innovations that were impossible with traditional rigid boards.
Pacemakers, cochlear implants, neurostimulators, and drug delivery systems all benefit from flex PCBs' ability to conform to body contours while maintaining reliable electrical connections. Our ultra-thin constructions minimize patient discomfort while maximizing device longevity.
From portable ultrasound probes to endoscopes and catheter-based sensors, flex circuits enable the miniaturization and flexibility required for modern diagnostic tools. High-density interconnects allow complex functionality in space-constrained applications.
Wearable health monitors, ECG patches, and continuous glucose monitors require flex PCBs that can withstand constant movement while maintaining signal integrity. Our designs optimize for both electrical performance and mechanical durability.
Robotic surgery systems, laparoscopic tools, and powered surgical instruments rely on flexible circuits to transmit power and signals through articulating joints and confined spaces.
Medical device manufacturers face intense regulatory scrutiny. Our comprehensive quality system is designed to support your regulatory submissions and ensure consistent product quality.
We support your design verification and validation requirements with documented DFM reviews, electrical testing protocols, and reliability testing programs tailored to your application.
Our manufacturing processes are validated according to medical device requirements. IQ/OQ/PQ documentation is available for critical processes, and we maintain statistical process control on key parameters.
We integrate with your risk management process, identifying potential failure modes and implementing controls to mitigate risks. Our FMEA-based approach ensures comprehensive risk assessment.
We provide the documentation you need for 510(k), PMA, and CE marking submissions, including material certifications, process validations, and reliability test reports.
Medical flex PCBs must withstand sterilization processes without degradation. We design and manufacture circuits compatible with all common sterilization methods:
Our standard medical-grade materials are compatible with EtO sterilization cycles. We can provide accelerated aging test data to verify long-term stability post-sterilization.
For gamma sterilization applications, we select materials with proven radiation tolerance and can provide post-irradiation testing to verify electrical and mechanical performance.
Reusable medical devices require autoclave-compatible flex circuits. Our high-temperature polyimide constructions withstand repeated steam sterilization cycles at 134°C.
For sensitive electronics, we offer constructions compatible with low-temperature hydrogen peroxide plasma sterilization.
Ultra-fine pitch flex circuit with 22 electrode contacts, designed for long-term implantation with full biocompatibility certification.
Thin, flexible circuit integrating signal conditioning, wireless transmission, and battery management for continuous cardiac monitoring.
Miniaturized flex PCB with fine-pitch BGA for CMOS sensor mounting, designed for repeated sterilization and high reliability.
We maintain ISO 13485:2016 certification and FDA registration for medical device manufacturing. Our facilities are audited annually by third-party registrars and regulatory bodies.
Yes, we can provide biocompatibility certifications for our medical-grade materials, including USP Class VI and ISO 10993 test reports from accredited laboratories.
We support medical device development from prototype quantities (as low as 5 pieces) through full production volumes. NRE costs are typical for custom tooling and process validation.
Every production lot receives unique identification. We maintain complete records of materials, process parameters, operator certifications, and test results. Traceability data is retained for the life of the product plus regulatory requirements.
Yes, our engineering team provides comprehensive DFM reviews for all medical device projects. We identify potential issues early and recommend design optimizations to improve yield, reliability, and cost.
