Qualifications: ISO 9001, ISO 13485, FDA Registered, Exhibitor in at least 2 MD&M and/or MEDTEC shows, Demonstrated experience in the medical device or IVD space
Spartronics is trusted
by customers world-wide in the production of their highly regulated complex
products and systems. Spartronics provides electronic contract manufacturing
services and assembly across vertical markets, including medical devices, life
sciences, commercial aerospace, defense, space and instrumentation and control
and space. Spartronics provides comprehensive contract manufacturing services,
ranging from printed circuit board assembly (PCBA) and subsystem integration to
full-box build (high-level assemblies).
Contract Manufacturing
Spartronics provides full circuit board assembly and subassembly services
across the globe, in one of our many manufacturing centers of excellence.
Spartronics specializes in the following assemblies:
- Circuit board assembly, including Surface mount technologies, complex secondary operations such as conformal coating, and inspection, offering automated optical inspection (AOI)
- Electromechanical
- Testing including flying probe, in-circuit (ICT), functional, ESS
- Sheet metal chassis for full box build applications
- Sub-assembly Wire harnesses
Spartronics works from concept and feasibility, engaging in critical early-stage discussions to provide product evaluation and determine feasibility, all the way to a final pilot production ensuring units are built under configuration controls, address optimization of the manufacturing process, throughput, supply chain and product planning down to the final production release.
Electrical engineering experience includes:
- AC and DC power supplies
- Embedded control systems
- Motor and motion control
- Optics integration
- Pneumatic and pump control
- Precision fluid metering
- RFx86 architectures
- Microfluidic interfaces
- Precision fluidic systems
- Prototyping and pilot builds
- System concepts and designs
- Thermal control systems
- Application software
- Cybersecurity techniques
- Embedded software and firmware
- Mobile application software
- Software design for medical devices
- Software quality assurance
Spartronics provides comprehensive upfront analysis to help OEMs improve product quality, minimize supply chain risks, and accelerate time to market with confidence. Readiness procedures, process controls and test strategies are consistently applied and documented to ensure products are built to customer specifications. Spartronics conducts upfront evaluations of all components, designs, and fabrication processes to optimize suppliers and technologies. Spartronics will recommend appropriate alternatives to minimize risks, reduce costs, and help customers to launch and scale their products.
Supply Chain
On-time delivery of advanced electrical and electromechanical products from contract manufacturers requires efficient supply chain planning and management tools. Spartronics provides value to OEM partners by consistently meeting timelines and budgets through management of the supply chain. Spartronics team of manufacturing and supply chain specialists work alongside OEM teams, utilizing analytical tools and Design for Supply Chain (DSC) methods to produce a comprehensive supply chain solution that includes component engineering, preferred supplier agreements, risk analysis, and supplier audits.
Quality
The medical devices that Spartronics contract manufactures range in complexity through FDA Classes I, II & III. Spartronics offers centers of excellence that are FDA-registered facilities meeting all FDA-regulated standards for the engineering and contract manufacturing of life-sustaining and critical-care devices.
- 21-CFR820
- FDA/QSR Registered Class I, II and IIII
- EC 60601-1
- ISO 9001
- ISO 13485
- ISO Class 8
- RoHS and REACH
- MDSAP
Spartronics expertise includes managing complex supply chains and oversight of outbound logistics from our facilities to your end user locations. OEMs also trust us to perform final system-level testing. Logistics support provided by Spartronics as your partner can include customer-owned, finished goods managed by Spartronics, emergency or priority shipments, export compliance and control regulations, kitting and cross-docking, labeling, logistic network planning, spare parts, and service depot support.
Aftermarket Solutions
Spartronics offers refurbishment in the field or servicing at Spartronics facilities in North America and Asia. Aftermarket services include obsolescence management, refurbishment, repair, spare parts support, software maintenance, and sustaining engineering. In addition to standard aftermarket support, Spartronics offers enhanced services which many contract manufacturers do not provide, such as: Decontamination, return logistics, loaner pool support, ongoing device history maintenance, tracking and genealogy, compliant investigation, and tracking.
Spartronics Brooksville Florida
30167 Power Line Road
Brooksville, FL
34602
United States
T 1-800-443-4132
E [email protected]
Spartronics Logan Utah
750 East 1600 North
North Logan, UT
84341
United States
T 1-866-898-4949
E [email protected]
Spartronics Milpitas California
1940 Milmont Drive
Milpitas, CA
95034
United States
T 1-408-957-1300
E [email protected]
Spartronics Plaistow New Hampshire
27 Hale Spring Road
Plaistow, NH
03865
United States
T 1-603-382-3840
E [email protected]
Spartronics Strongsville Ohio |Medical Center of Excellence
22740 Lunn ROad
Stronsgville, OH
44149
United States
T 1-440-878-4630
E [email protected]
Spartronics Tecate Mexico | Low Cost Country
Calle Cuchuma 7000-D Parque Industrial El Baio
Tecate, Baja California
Mexico
21440
Mexico
T 011.52.665.655.5279
E [email protected]