Life-Changing Medical Electronics
Diagnostic, Imaging, Robotic, and Therapeutic Markets
Improving the Outcome
From electrophysiology to point-of-care diagnostics, technology in healthcare is evolving faster than ever before. Here at Naprotek, we're proud to manufacture electronics assemblies for medical devices that transform the lives of patients all over the world. Our ISO13485 certified factories leverage proven quality systems and current good manufacturing practices (cGMP) that comply with stringent FDA requirements.
With over 25 years of medical device manufacturing experience, Naprotek has become a trusted partner for pioneers innovating imaging, diagnostic, robotic, therapeutic, and interventional solutions. Whether you're looking to launch a new product or to expand your presence in the market, Naprotek can help you improve the outcome.
Improving the Outcome
From electrophysiology to point-of-care diagnostics, technology in healthcare is evolving faster than ever before. Here at Naprotek, we're proud to manufacture electronics assemblies for medical devices that transform the lives of patients all over the world. Our ISO13485 certified factories leverage proven quality systems and current good manufacturing practices (cGMP) that comply with stringent FDA requirements.
With over 25 years of medical device manufacturing experience, Naprotek has become a trusted partner for pioneers innovating imaging, diagnostic, therapeutic, and interventional solutions. Whether you're looking to launch a new product or to expand your presence in the market, Naprotek can help you improve the outcome.
Progressing Healthcare Through Innovation
Exceeding Expectations
We build electronics that both practitioners and patients depend upon in ambulances, operating rooms, laboratories, and at the point-of-care. Our program management, engineering, and quality teams appreciate the gravity of the products they manufacture and are trained to deliver robust, reliable, and repeatable solutions.
Our manufacturing processes and quality systems are purpose-built to serve FDA regulated products and our factories carry the certifications to support compliance. When you're looking for a new development or manufacturing partner, Naprotek has experience you can lean on.
Life-saving Technologies
Our medical partners develop technologies that span the practice of medicine. Some of the applications we support include:
- DNA / genome sequencing & laboratory equipment
- RF ablation, endoscopy, & handheld instruments
- Imaging & radiology
- Surgical robotics
- Patient monitoring including CGM
- Point-of-Care (POC) & In-Vitro Diagnostics (IVD)
- Therapeutics and infusion
- Hemodialysis
We're With You Every Step Of the Way
Comprehensive Electronics Assembly & Program Management Services
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Manufacturing
Although we feature high speed pick-and-place machines, multi-zone reflow ovens, and dual wave / chip wave solder machines, our heart and soul is the people on the assembly floor. Your products are in the hands of the most talented group of manufacturing professionals.
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Microelectronics
When it comes to sophisticated board designs that include MEMS, sensors, or connectivity we're here to support products from prototype through to production. In addition to conventional electronics assembly techniques, Naprotek offers microelectronics design and manufacturing services in state-of-the-art ISO 7 and ISO 8 rated clean rooms.
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Engineering
We offer a variety of design services to reduce manufacturing time and development costs. Advanced engineering in microelectromechanical systems make the impossible, possible. Electrical engineering and PCB layout turn your ideas into reality. Design for manufacturability (DFM) and design for test (DFT) gets your product ready to scale.
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Test & Inspection
Our engineers work closely with programs to ensure they have the necessary test and inspection support they need. We offer a full range of services including flying probe and in-circuit test (ICT), solder paste inspection, automated optical inspection (AOI), 3D X-ray imaging, microscopic inspection, and functional test.
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Rapid Prototyping
We help our customers get their products to market faster by transforming their concepts into manufacturable designs. Using established systems and automated tools, we can deliver quick turn printed circuit boards in as little as one to five days to help you maintain your manufacturing velocity.
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New Product Introduction
Bringing a product to market requires a knowledgeable product launch management team with manufacturing readiness expertise. Our dedicated team manages each product such that the final design transitions seamlessly into our manufacturing process with clear documentation, defined test procedures, and inspection readiness.
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Integration
We collaborate with our customers to deliver solutions from PCBA through finished product. Our integration services includes the assembly of boards-to-box, including sub-assembly, box-to-box, and full system integration. We support a variety of top-level assembly configurations and industry unique processes.
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Supply Chain
Our team optimizes BOMs, provides insights to alternate parts, mitigates counterfeit components, and supports last time buys (LTB). We source from distribution, direct from customer, or trusted kitting partners. On an as-needed basis, we offer Build-to-Order (BTO), Configure-to-Order (CTO), RMA processing, and Kanban services.
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Quality
From early design to volume production, our quality processes comply with the stringent requirements of the medical device industry. To meet these exacting standards, we routinely audit our factories, refine our quality system, and maintain a quality management team to support day-to-day activities and drive continuous process improvement.
Our Pledge to Quality
From early design to volume production, our quality processes comply with the strict demands of the medical device and life science industries. We have an established QMS and leverage our customers IQ/OQ/PQ or EVT/DVT/PVT process flow.
Our factories and manufacturing professionals are certified or comply to the following certifications and standards:
- ISO9001:2015 — Quality Management Systems
- ISO13485:2016 —Quality Management Systems — Medical Devices
- IPC-A-610 — Acceptability of Electronics Assemblies
- IPC-A-620— Requirements and Acceptance for Cable and Wire Harness Assemblies
- IPC-7711/7721 — Rework, Modification and Repair of Electronic Assemblies
- IPC-J-STD-001 — Requirements for Soldered Electrical and Electronic Assemblies
- ISO 14971 — Application of risk management to medical devices
- IEC 60601-1 — Medical electrical equipment
- IEC 62304 — Medical device software
Case Study: Opsis IQ
Using Design for Manufacturability (DFM) principles, Naprotek worked collaboratively with Opsis engineers to establish a manufacturing workflow, recommend design changes, identify component alternates, modify assembly processes, and more.
Let Us Know More About Your Project
Contact us to learn more about our capabilities in manufacturing medical electronics.
