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Advanced medical device manufacturing solutions from concept through production with precision molding, prototyping and assembly expertise.
New Concept Technology has the innovative manufacturing solutions and experienced services your medical organization needs to turn your medical device product ideas into reality. We provide automated medical device manufacturing solutions, however complex. From rapid prototyping to custom overmold and injection molding solutions, our capabilities address your unique manufacturing requirements.
As designs and materials for medical devices have become more complex, we have searched for ways to cut down on material costs and speed up the manufacturing process for the benefit of our medical clients. Our team of product and automation engineers have proven experience in the medical industry and are here to partner with product designers to manufacture your complex medical device components.
New Concept Technology’s medical device manufacturing process is built to move your program efficiently from concept to production while meeting the strict quality and regulatory standards the medical industry demands. With in-house engineering, cleanroom capabilities, advanced molding, and expert assembly services, we support complex medical programs from start to finish under one roof.
We begin by reviewing your device concept, application requirements, and regulatory considerations. Our engineering team works with your team to understand performance goals, material needs, and production volumes, ensuring a clear and practical path forward before development begins.
Our rapid prototyping services allow your organization to develop, test, and refine medical device designs quickly. This stage reduces development costs, accelerates time to market, and gives your team early confidence in manufacturability before tooling is committed.
We develop the mold tooling, process controls, and production methods required for your specific program. From injection molding and overmolding tooling to medical process controls for hermetically sealed architectures, we engineer every detail for precision and repeatability.
Production takes place in our ISO 14644-1 Class 6 certified cleanroom environment (Federal Standard 209E 100,000). Our facility is configured to meet strict contamination control requirements and supports the specialized demands of medical device molding and component production.
Our expert assembly services cover your program from proof of concept to steady-state production. We offer manual, semi-automated, fully automated, micro-assembly, and conventional scale assembly, all customizable to meet your production requirements and quality expectations.
Every finished product moves through rigorous quality inspection aligned with ISO 13485:2016 and ISO 9001:2015 standards. We track quality from receipt of raw material through final inspection to ensure your medical devices meet customer and regulatory requirements before leaving our facility.
We offer the rapid design and prototyping capabilities you need to develop, test and manufacture products for your most critical medical procedures. With our rapid medical prototyping services, your organization can:
New Concept Technology’s facilities are among the best in the world with a state of the art class 100K clean room, ISO 14644-1 Class 6 Certified, (Federal Standard 209E 100,000).
We excel in meeting all customer quality requirements from receipt of raw material through final inspection of finished product. Configured with flexibility in mind to support our wide range of medical manufacturing and assembly services, we’re ready to serve your needs.
We use innovative molding equipment and extensive molding experience to assist with medical device molding needs. We offer both overmolding and injection molding services to meet your project’s unique requirements.
We specialize in custom overmold solutions for medical products. Our extensive experience enables us to offer high-value services in a rapid timeframe. Our expertise resides in:
We’re pioneers in advanced molding efficiency and manufacturing, driven by our customer-first philosophy and desire to satisfy your unique injection molding requirements. Our expert team offers rapid prototype medical device molds and mold tooling production for medical institutions and companies. With our injection molding capabilities, your organization can experience more project flexibility and extraordinary results.
We’re an established industry leader in fabrication and assembly concepts. We prioritize safety, quality and efficiency throughout all of our assembly processes to ensure you get the most value from your medical devices. With our assembly services, you can trust you will get your innovative product on time and with a competitive edge.
Each of our assembly options is customizable to meet your production needs. We follow efficient assembly processes to enhance your product’s quality while providing cost savings. From proof of concept to steady state production, our expert assembly services include:
New Concept Technology offers tailor-made solutions for your organization’s unique manufacturing needs. Our processes have been proven to enhance product quality while optimizing operational efficiency. With extensive design expertise, decades of experience and the industry’s best tools, we meet your quality requirements from the moment we receive your raw material to final inspections for your finished product.
We pride ourselves on having some of the best facilities in the world. We hold ISO 14644-1 Class 6 (Federal Standard 209E 100,000) and ISO 13485:2016 certifications to show our commitment to high clean room and quality management system standards. Configured to prioritize flexibility, our location is equipped with everything we need to offer a wide range of medical manufacturing and assembly services that address your needs.
New Concept Technology provides medical organizations with a trusted manufacturing partner that combines innovative molding technology, cleanroom capabilities, and certified quality systems. From rapid prototyping to high-volume production, our services reduce costs, accelerate time to market, and support your most critical medical device programs.
Our ISO 13485:2016 certification demonstrates our commitment to medical device quality management. Every product is tracked from raw material receipt through final inspection, ensuring compliance with customer and regulatory requirements at every stage.
Our ISO 14644-1 Class 6 certified cleanroom (Federal Standard 209E 100,000) provides the controlled environment medical device production demands. Configured for flexibility, our facility supports a wide range of medical manufacturing and assembly programs.
Rapid prototyping and integrated manufacturing capabilities allow your organization to move quickly from concept through production. Quick turnaround times and streamlined processes help you get innovative devices to market without unnecessary delays.
By combining rapid prototyping, design engineering, and production under one roof, we help medical organizations reduce the cost of device development. Our single-source model streamlines your supply chain and eliminates the overhead of managing multiple vendors.
From custom cable overmolding with hermetically sealed architectures to rapid prototype injection molds and mold tooling production, our molding expertise supports the specialized requirements of medical device manufacturing with precision and reliability.
Our product and automation engineers bring proven experience in the medical industry and partner closely with product designers throughout the program. Their expertise in material science, mold flow, and medical process controls supports complex device requirements from day one.
New Concept Technology manufactures a wide range of medical device components, including injection molded parts, custom cable overmolds, and complex assemblies for critical medical procedures. Our capabilities include rapid prototyping, mold tooling production, micro-assembly, and automated assembly for medical organizations developing both new and established device programs.
New Concept Technology holds ISO 13485:2016 certification for quality management systems specific to medical devices, along with ISO 9001:2015 for general quality management and ISO 14644-1 Class 6 certification for our cleanroom environment. These certifications reflect our commitment to the quality, safety, and regulatory standards the medical industry requires.
Yes. Our state-of-the-art cleanroom facility is ISO 14644-1 Class 6 certified (Federal Standard 209E 100,000). It is configured with flexibility in mind to support a wide range of medical manufacturing and assembly services. We excel in meeting customer quality requirements from raw material receipt through final inspection of finished medical products.
Our medical assembly services include manual assembly, semi-automated and fully automated assembly, micro-assembly, and conventional scale assembly. Each option is customizable to meet your production needs, and all are designed to enhance product quality while providing cost savings from proof of concept through steady-state production.
Our team partners with product designers from the earliest stages of development. We provide rapid prototyping to reduce development costs and accelerate time to market, followed by tooling development, cleanroom manufacturing, and full assembly services. As a single-source partner, we streamline your supply chain and provide guidance for developing an effective manufacturing strategy throughout the entire program lifecycle.
At New Concept Technology, our primary goal is to provide medical manufacturing solutions that deliver quality products and ensure your success. We use innovative molding technology to bring your device ideas to life. Our superior customer service and exceptional engineering expertise set us apart in many markets, including the medical device market. Contact us online today to learn more about what makes us a great injection molding partner.