Custom PCBA Design for Medical Applications

We offer fully customized PCBA design services to meet the unique requirements of medical devices. Whether you’re developing a diagnostic tool, monitoring system, therapeutic device, or implantable, we collaborate closely with you to understand the specific needs of your device. Our design process focuses on factors such as signal integrity, power management, size constraints, and heat dissipation, ensuring that your device’s electronics are optimized for both performance and safety.

High-Quality Sourcing and Component Selection

Choosing the right components is crucial in medical device PCBA development. Our experienced engineers select the best components for your device, considering both performance and reliability. We work with trusted suppliers to ensure that only medical-grade, certified components are used, meeting the rigorous standards of the healthcare industry. This guarantees that your device’s PCBAs meet the highest quality standards and are compliant with regulatory requirements.

Prototyping and Testing

Our rapid prototyping capabilities allow us to quickly produce functional PCBAs for your medical device. We employ state-of-the-art tools and techniques, including automated testing, design for manufacturability (DFM) analysis, and environmental stress testing, to ensure that your PCBAs perform as expected in real-world medical environments. We thoroughly evaluate all components, connections, and assembly methods to identify any issues early in the process, ensuring a smoother transition to final production.

Design for Compliance and Reliability

Medical devices require stringent regulatory compliance, and PCBAs are no exception. Our design and manufacturing processes adhere to industry-specific standards such as ISO 13485, IEC 60601, and the FDA’s 21 CFR Part 820. We focus on designing PCBAs that meet or exceed these regulatory requirements, ensuring that your device is not only effective but also compliant with global medical device regulations. Our team also designs for reliability, ensuring your PCBA performs under the demanding conditions of healthcare environments, including durability, long-term performance, and patient safety.

Manufacturing and Assembly

Once the design is finalized and tested, we move to scalable manufacturing and assembly. We partner with companies which has advanced automated assembly techniques to ensure precision and repeatability in the production of PCBAs.

Rigorous Quality Assurance and Testing

We understand that medical device PCBAs must meet the highest standards of reliability and safety.

Our comprehensive quality assurance process includes electrical testing, in-circuit testing (ICT), automated optical inspection (AOI), and functional testing to verify that the assembled PCBA performs as intended. We also conduct environmental and stress testing to simulate real-world conditions, ensuring that the PCBA will perform reliably in medical settings.

Post-Market Support and Lifecycle Management

Our commitment to your success doesn’t end with production. We provide ongoing support throughout the lifecycle of your medical device. From firmware updates to component obsolescence management, we ensure that your PCBA remains up-to-date and performs optimally. Our engineering team is available to assist with any troubleshooting or updates needed to maintain compliance and performance in the field.