Our Expertise:
We have more than two decades of experience in manufacturing medical devices for a wide array of clients, including Fortune 500 companies and new high-tech startups based in Silicon Valley Bay Area. Our core business segment centers around medical device manufacturing, a sector that requires precision and strict adherence to quality processes and regulations. We excel in this specialized domain, demonstrating expertise and proficiency
Our Comprehensive Services:
We offer comprehensive medical device manufacturing services, including Design for Manufacturing (DFM) and Design for Test (DFT) support. Additionally, our engineering expertise extends to prototyping, testing, system assembly and guidance for new product introductions. Our proactive approach to early planning for materials and production ensures accelerated time-to-market for our clients.
Expert Team for High-Mix Low-Volume Manufacturing:
Medical device contract manufacturing often involves high-mix low-volume production, which demands adequant resource commitment and effective management support. We've cultivated a team with extensive training and experience in this specialized area. Our robust infrastructure for medical device manufacturing is built upon this foundation. Moreover, our remarkably stable workforce, with an extremely low attrition rate, ensures consistent delivery of high-quality products on time, without any surprises.
Our Rigorous Quality Process:
We adhere to the highest quality standards, including ISO 9001, ISO 13485, and UL, etc. As an FDA-registered entity, we maintain medical device history records (DHR) in accordance with FDA regulation.
We maintain a Manufacturing Execution System (MES) equipped with real-time barcode data collection devices. This system enhances quality control, ensures traceability, and guarantees regulatory compliance. Furthermore, we customize our traceability system to meet specific customer requirements.
Recognized by Our Customers:
Our unwavering commitment to excellence in high-mix low-volume manufacturing has earned us recognition as the preferred vendor, particularly within the medical device industry. Our service is defined by quality, speed, responsiveness, and unwavering consistency, making us a trusted partner for all your manufacturing needs.
Option for Offshore Manufacturing:
For high-volume products, we offer offshore manufacturing services in low-cost Taiwan, enhancing competitiveness and allowing our clients to capture a larger market share. Taiwan boasts exceptional supply chains for electronic products.
Best-in-Class Services
We offer best-in-class Medical Device Contract Manufacturing Services to leading and new startup medical equipment OEM companies. Our services include complete manufacturing solutions from PCB board assembly, box assembly to testing and fulfillment. We provide turnkey, consignment, and hybrid material solutions tailored to customer requirements. Our reputation is built on high quality, on-time delivery, and responsive services.
Manufacturing Execution System (MES)
Sparqtron has implemented an integrated Manufacturing Execution System (MES) for delivering the superior medical devices. Our MES, coupled with real-time barcode data collection devices, enhances quality control and ensures traceability and regulatory compliance. We customize our traceability system to meet specific customer needs.
Maintaining Medical Device History Records
Sparqtron maintains medical device history records (DHR) in accordance with FDA regulations. Our Quality System ensures that DHRs are maintained in alignment with the Device Master Record (DMR).
Well-Planned & Attention to Detail
Your project is in good hands with us. Our proactive planning, attention to detail, and comprehensive engineering support enable us to quickly deliver high-quality prototypes and NPIs on schedule, significantly speeding up the Time-to-Market for you.
Do It Right The First Time
We offer pre-DFM services to help design engineers correct any issues before finalizing designs for prototype builds. Our attention to detail and value-added engineering expertise ensure that we get it right the first time. We also provide post-DFM services to minimize manufacturability issues for future production builds.
Leverage Our Buying Power
Our component engineers help find alternative parts to solve lead time problems and reduce material costs. Our Far East procurement team can source materials from Asian suppliers, further reducing your costs.
We Are a Partner You Can Trust
We understand the unique challenges of manufacturing medical devices and are committed to helping our clients bring their products to market efficiently and timely. With a proven track record of success, we are confident that we can help you meet your manufacturing goals.
