At Altest Corporation, has been providing the medical equipment industry with PCB electronic assembly services and contract manufacturing since 1995. We follow all relevant best practices during the circuit board assembly process. As a result, we are an electronic medical device manufacturer that is uniquely equipped to help you bring to market reliable pumps, robotics, power supplies and other medical devices.
PCB layout engineering requires careful consideration of several factors to ensure the final board meets performance, manufacturability, and reliability standards.
We fabricate and assemble high-reliability medical PCBs engineered for life-critical healthcare applications. Our controlled manufacturing approach emphasizes precision, traceability, and long-term reliability across diagnostic, monitoring, and therapeutic medical devices. Our medical PCB assembly and electronic manufacturing services support a wide range of advanced healthcare technologies where performance and safety are non-negotiable.
Medical electronics demand exceptional manufacturing accuracy, component reliability, and long-term operational stability. Our engineering team specializes in assembling multilayer, HDI, rigid-flex, flex, RF, high-speed digital, and miniaturized PCB assemblies using advanced Surface Mount Technology (SMT), Through-Hole Technology (THT), and mixed-technology assembly processes. We support fine-pitch components, BGAs, CSPs, QFNs, microelectronics, and high-density interconnects while optimizing thermal management, signal integrity, and Design for Manufacturing (DFM) to ensure dependable performance in critical healthcare environments.
With decades of expertise in Electronics Manufacturing Services (EMS), Altest Corporation is a trusted manufacturing partner for medical device manufacturers, healthcare technology companies, and OEMs worldwide. Our end-to-end capabilities—including PCB design support, fabrication, component sourcing, PCB assembly, cable and wire harness integration, box build assembly, firmware programming, functional testing, and final system integration—enable us to deliver complete turnkey manufacturing solutions. Our commitment to precision engineering, advanced process control, and continuous quality improvement helps customers accelerate product development while maintaining the highest levels of reliability and patient safety.
Find answers to common questions about ISO 13485 certification, FDA compliance, traceability, and manufacturing standards for life-critical medical devices.
The cornerstone of medical device manufacturing is ISO 13485:2016 certification. Altest Corporation is fully ISO 13485 certified, meaning our quality management systems meet the rigorous regulatory requirements necessary to design and manufacture safe, reliable electronics for the healthcare industry.
Yes. We have extensive experience building electronics for all classes of medical devices. We adhere strictly to IPC Class III manufacturing standards, which are mandatory for Class III (life-sustaining or implantable) medical devices where hardware failure is absolutely unacceptable.
Traceability is critical for FDA audits and potential product recalls. We employ a robust, automated Shop Floor Control System (MES) that logs the exact lot code, date code, and supplier for every single component placed on a specific board, providing complete end-to-end traceability down to the individual serial number.
Yes. Wearable health monitors, hearing aids, and implantables require electronics to be incredibly small, lightweight, and adaptable to human body contours. We specialize in fabricating and assembling high-density Flex and Rigid-Flex circuits using bio-compatible polyimide materials to meet these demanding form factors.
Counterfeit components in medical devices pose a fatal risk. We source primarily from authorized franchised distributors. When forced to use the open market for obsolete parts, our incoming inspection lab strictly adheres to the AS6081 counterfeit mitigation standard, utilizing X-ray, decapsulation, and curve tracer testing to verify absolute authenticity.
Medical boards must be exceptionally clean to prevent ionic contamination, which can cause dendritic growth or corrosion over time. We utilize advanced aqueous and semi-aqueous defluxing wash systems, followed by ROSE (Resistivity of Solvent Extract) testing or Ion Chromatography to scientifically verify the boards meet stringent medical cleanliness standards.
Yes. Medical electronics are frequently exposed to bodily fluids, harsh sterilization chemicals, and moisture. We apply specialized, medical-grade conformal coatings (such as silicone, acrylic, or parylene) to hermetically seal and protect the PCBA without interfering with delicate sensors or high-frequency signals.
We employ a multi-tiered testing strategy. This includes 100% 3D SPI and 3D AOI during assembly, 3D X-Ray (AXI) for hidden BGA joints, and Flying Probe testing for electrical continuity. Finally, we perform System-Level Functional Testing (FCT) to simulate the device's real-world operation and guarantee perfect functionality before shipping.
Absolutely. We frequently partner with medical device startups to transition their designs from proof-of-concept prototypes to scalable production. Our engineers provide critical Design for Manufacturing (DFM) and Design for Testing (DFT) feedback early on, ensuring the product is manufacturable, cost-effective, and positioned for successful regulatory approval.
Protecting your IP and potential patient data is paramount. Our entire Silicon Valley facility operates under strict ITAR and NIST SP 800-171 cybersecurity compliance. All sensitive CAD files, schematics, and proprietary firmware are handled within secure, encrypted, U.S.-based servers with highly restricted physical and digital access controls.
Partner with Altest Corporation for your next high-reliability PCB fabrication and turnkey SMT assembly project. Our engineering team is ready to review your gerber files and provide a detailed, competitive estimate.
