Comprehensive Medical Device Contract Manufacturing Services
In the precision-driven world of medical device manufacturing, quality and reliability are crucial. With over 20 years of experience, we are a trusted partner for Class I, II, and III medical devices, providing comprehensive contract manufacturing solutions.
Specializing in High-Mix, Low-Volume (HMLV) medical equipment production, we have the advanced infrastructure and expert team required to handle complex medical device contract manufacturing. Our customizable assembly processes ensure your products reach the market quickly and meet the highest industry standards.
Success Story: Building a Highly Sophisticated and Complex Device
This medical device system comprises over 1,600 parts and involves a very complex process. It also requires an extremely high degree of precision.
Contact Us today to learn more about how our expertise can accelerate your medical device development.
Speed up your Time-to-MarketOur SVP of Engineering and Manufacturing brings over 30 years of experience in the electronics contract manufacturing industry. They have been a pioneer in quick-turn PCB (Printed Circuit Board) prototyping and New Product Introduction (NPI), previously leading global NPI operations at a top tier EMS vendor. Their expertise ensures the seamless integration of new products into manufacturing, a key factor in accelerating time-to-market for innovative electronic products.
Thanks to the wealth of best practices they have developed, we are recognized as leaders in quick-turn PCB prototyping and NPI. Our accuracy and efficiency have earned us a stellar reputation among engineers in Silicon Valley, the global hub of technological innovation.
Contact Us today for a free consultation on how we can help bring your products to market faster.
Success Story - Saving a Medical Distributor’s Business:
A medical distributor from China reached out to us for help with their bone density testing equipment, which is their main business and highly successful in China. The original manufacturer of this product had gone out of business, leaving only the CFO available to assist. With the CFO’s help, we obtained the necessary product documentation for our study. He also referred us to a technician who used to assemble the system.
Our competent engineers, along with the technician, spent considerable time investigating the issue. Ultimately, we were able to manufacture the product without any problems. We are very pleased to have played a role in saving this business and helping it continue to thrive.
We collaborate closely with clients to understand product requirements and specifications. We assist with medical device engineering services, from initial concept through to final design, ensuring manufacturability and regulatory compliance.
Patient-centric design: "Patient safety is our top priority. We provide design review to our client for designing and manufacturing quality medical devices with the utmost consideration for patient well-being."
We do DFM (Design for Manufacturing) into the early stages of the process to Prevent the need to rework elements later in the process. We make them fit with manufacturing realities, minimize costs because issues can be dealt with early without double-work.
Our engineering support for pre-design for manufacturability (DFM) services ensures that design issues are addressed early, reducing the need for costly revisions during prototype builds. We also provide post-DFM services to minimize manufacturability challenges in future production
We define manufacturing processes, including equipment and machinery requirements, establish quality control parameters, and develop detailed process documentation to ensure consistent, high-quality production.
We offer a wide range of medical device assembly services, including:
New Product Introduction (NPI) is a critical process that bridges the gap between product development and mass production of medical equipments. We have a a well-defined NPI process to identify potential issues earlier, streamlining process for mass production, cost optimization, and quality assurance.
Verification is a crucial process in the development and manufacturing of medical devices, ensuring that the device is built correctly according to design specifications. So that the devices are safe, effective, and meet regulatory standards.
Testing: We utilize state-of-the-art testing equipment to perform rigorous functional and performance testing on every device we manufacture. This ensures each product functions flawlessly before reaching patients.
We apply clear, accurate product labels and package products according to regulatory requirements and customer specifications.
Regulatory Compliance: We ensure that all processes adhere to ethical standards and comply with relevant medical device regulations (e.g., FDA, ISO 13485, UL, CE) and regularly update our compliance procedures in meeting the highest safety and quality requirements for patient well-being.
Structured Methodology: Our quality control methodology is designed to ensure the highest levels of safety, effectiveness, and reliability for medical devices. This includes thorough material inspections, controlled manufacturing processes, and comprehensive testing, which are crucial for medical device assembly and manufacturing.
Traceability and Transparency: We maintain a comprehensive traceability system that allows us to track every component and material used in each device. This ensures we can quickly identify and address any potential quality issues. We dedicated to manufacture medical equipment meeting the quality standards and preventing defects and recalls while safeguarding patient safety. We maintaimaintains medical device history records (DHR) in accordance with the requirements of the FDA regulations. Our Quality System ensures that DHR's are maintained in accordance with the Device Master Record (DMR).
Computerized Manufacturing Execution System (MES), coupled with real-time barcode data collection, to track the movement of components and products throughout the manufacturing process. It enhances quality control and ensures traceability and regulatory compliance per medical regulations, such as unique device identification (UDI), etc. We customize our traceability system to meet specific customer needs for medical device and equipment manufacturing.
Continuous improvement: "We are committed to continuous improvement in our quality control processes. We regularly evaluate and update our procedures to ensure we remain at the forefront of medical device safety"
Regular Quality Review Meeting: We conduct regular quality meetings with our OEM customers to ensure we consistently meet their requirements and enhance their satisfaction. During these meetings, we review the mutually agreed-upon KPIs to drive continuous improvement.
We coordinate with logistics providers for efficient product delivery to the designated locations, manage inventory, and optimize distribution channels to reduce costs and speed up time-to-market for medical equipment manufacturing.
It is a critical aspect of the services we provide to our customers, including repair, warranty services, technical support with troubleshooting, spare parts management, handling returns, repairs, and refurbishments, etc.
We implement environmentally friendly practices, such as waste reduction and energy conservation, and source materials from sustainable suppliers when possible.
We have adequate capacity at our Fremont, CA assembly facility, and our Taiwan assembly facility offers an excellent option for high-volume products. We provide competitive offshore manufacturing services at our Taiwan facility, enhancing our clients’ competitiveness and helping them capture a larger market share. Taiwan boasts exceptional supply chains for electronic products, further supporting our high-quality manufacturing capabilities.
We assign dedicated Customer Focus Team (CFT) to assist you at every stage of your project. From initial consultation to final delivery. Our CFT team works closely with you to proactively understand your unique requirements, help you well-plan your projects early, and provide tailored solutions. Our collaborative approach ensures seamless communication and successful project outcomes.
We have a culture of continuous improvement and are always open to your feedback and suggestions. Your opinions are very important to us.
Developing a lasting partnership in medical device manufacturing goes beyond typical manufacturing relationships. It's built on shared goals, values, and a long-term vision for success. As your strategic partner, we invest in your success by providing comprehensive support that extends beyond production.
Our unwavering commitment to excellence in precision medical equipment assembly has established us as a preferred vendor in the industry. We pride ourselves on delivering:
With our proven track record, we have confidence in meeting your manufacturing needs with precision and efficiency. Count on us as your trusted partner for all your medical device manufacturing requirements.
Speed up your Time-to-Market
Sparqtron Corporation Tel: 1-510-657-7198 EXT. 200
eMail: info@sparqtron.com
Address: 5079 Brandin Court, Fremont, California CA 94538, USA
(San Francisco Bay Area, near San Jose, California)
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