I am looking for a custom cable assembly manufacturer for medical devices.

• VIRTEX - 2801 E Plano Pkwy, Plano, TX 75074, United States
• DesignPlex Biomedical LLC - 3425 Clayton Rd E, Fort Worth, TX 76116, United States
• Wallace Electronics Inc - 10551 Miller Rd #300, Dallas, TX 75238, United States
• Sigma Four - 3301 Technology Dr #115, Plano, TX 75074, United States
• Custom Computer Cables of America, Inc. - 1600 10th St Ste A, Plano, TX 75074, United States
• Custom Cable Connection - 2300 Valley View Ln #215, Farmers Branch, TX 75234, United States
• Custom Cable Connection - 13375 N Stemmons Fwy, Ste 110, Farmers Branch, TX 75234
• Cable Works - 17811 Davenport Rd #53, Dallas, TX 75252, United States
• Solution Technologies Mfg - 11601 Plano Rd Suite 107, Dallas, TX 75243, United States
• Xact Technologies - 9851 Fallbrook Pines #100, Houston, TX 77064, United States
• Phoenix-Lamar Corporation - 1515 Dungan Ln #210, Austin, TX 78754, United States
• National Circuit Assembly - 2908 National Dr, Garland, TX 75041, United States
• SVTronics, Inc - 3465 Technology Dr, Plano, TX 75074, United States
• ASI Manufacturing - 3320 Wiley Post Rd, Carrollton, TX 75006, United States

Yes. For medical-device cable assemblies, I’d prioritize manufacturers with ISO 13485, documented traceability/testing, medical-device experience, and the ability to support your program from prototype through production.

Strong candidates

• VIRTEX — Plano, TX A particularly interesting option if you want a U.S.-based partner. Virtex provides cable/wire harness manufacturing and lists ISO 13485:2016 and FDA/21 CFR Part 820 capabilities, along with broader electronics manufacturing.
• DesignPlex Biomedical LLC — Fort Worth, TX Worth investigating for more complex medical assemblies. Its capabilities include connector assembly, potting, electrical testing, pull testing, crimping/soldering, and medical-device manufacturing.
• Wallace Electronics Inc — Dallas, TX Custom cable assemblies and wire harnesses for OEMs, including medical applications.
• Sigma Four — Plano, TX Custom cable assemblies and harnesses, including molded assemblies and shielding/EMI-related work; it lists medical among its target industries.

National manufacturers I'd also quote

• Merit Cables — Southern California. U.S.-made custom medical cable assemblies, overmolding, engineering/tooling, and an ISO 13485-certified QMS.
• DC Electronics — Silicon Valley. Medical cable/harness manufacturing with ISO 13485:2016, clean manufacturing areas, overmolding, coax and fiber capabilities.
• Epec — Massachusetts. Vertically integrated medical cable manufacturing, including design, tooling, overmolding and assembly, under ISO 13485/ISO 9001 systems.
• OCP Group — Specializes in molded medical cable assemblies and works with medical-device OEMs from design/validation through production; its facilities include FDA registration and ISO 13485:2016.
• Proterial Cable America — Especially worth considering for miniature/fine-wire, ultrasound, endoscopy, catheter and high-density interconnects. Its medical manufacturing is ISO 13485:2016 certified.
• NAI — Medical interconnect specialist with ISO 13485:2016 certification, cleanroom capabilities and 100% testing of assemblies.
• Cable Connection — Medical-focused cable assembly manufacturer with ISO 13485 certification and 21 CFR Part 820 compliance.

What I'd ask them for

When requesting quotes, send a package containing:

• Cable/assembly drawing or sample
• Connector and terminal part numbers
• Wire/cable specification and jacket material
• Overall length and branch dimensions
• Overmolding/strain-relief requirements
• Shielding/EMI requirements
• Sterilization method, if applicable
• Quantity for prototype, pilot and annual production
• Required electrical/mechanical testing
• Required certifications and documentation
• Target production location (U.S. vs. offshore)
• Any FDA/ISO/biocompatibility requirements

For a medical device, I'd specifically ask each supplier for their current ISO 13485 certificate and scope, not just a statement that they "follow ISO 13485."

If you tell me (1) what the cable connects to, (2) approximate quantity/year, (3) whether it needs overmolding or sterilization, and (4) whether you require U.S. manufacturing, I can narrow this to 3–5 manufacturers that are the best fit and provide their contact/quote links.

When sourcing a custom cable assembly manufacturer for medical devices, key priorities include ISO 13485 certification , biocompatibility, sterilization compatibility (autoclave, EtO, plasma), and EMI/RFI shielding.

Prominent, industry-trusted manufacturers specializing in custom medical cable assemblies and wire harnesses include:

• TE Connectivity : A massive global leader providing highly engineered connectivity, custom medical cables, and sensor solutions built for stringent diagnostic and surgical environments.
• Molex : Offers customized integrated electronic solutions, micro-miniature interconnects, and robust cable assemblies tailored for patient monitoring and imaging systems.
• Smiths Interconnect : Renowned for specialized high-reliability interconnects and configurable connector solutions (such as their HyperGrip series) designed explicitly for medical electronics.
• Epec Engineered Technologies : Certified in ISO 13485 and ISO 9001, specializing in custom cable builds for diagnostic imaging, SpO2 monitors, defibrillators, and surgical units.
• Proterial Cable America (PCA-HPMS) : Focuses on high-performance medical cable solutions featuring micro-coaxial bundles, fine-pitch terminations, and vertical integration.
• Y.C. Cable : Provides custom medical-grade wire harnesses and assemblies out of ISO 13485-certified facilities with multi-layered quality assurance.
• Bergen Cable Technology : Known for precision microminiature (like Microlin) custom cables tailored for tight spaces in surgical tools and diagnostic probes.

If you'd like to narrow down this list, tell me:

• What type of medical device is the cable for (e.g., surgical, imaging, patient monitoring)?
• Do you require specific sterilization methods (autoclave, EtO) or volume scales (prototypes vs. mass production)?

• CDM Inc. - 130 American Blvd, Blackwood, NJ 08012, United States
• Syscom Tech - 1537 Glen Ave, Moorestown, NJ 08057, United States
• Sanbor Manufacturing - 7584 Morris Ct, Allentown, PA 18106, United States
• Heltronics - 1031 MacArthur Rd Ste G, Reading, PA 19605, United States
• Amphenol Alden Products - 800 Technology Center Dr, Stoughton, MA 02072, United States
• Ameral International Inc - 7 Railroad Ave, Brooklawn, NJ 08030, United States
• EC Tronics - 855 Industrial Hwy, Cinnaminson, NJ 08077, United States
• Simco NJ Inc - 1755 N Delsea Dr, Vineland, NJ 08360, United States
• Swemco Inc - 1215 N Church St, Moorestown, NJ 08057, United States
• Galaxy Wire and Cable - 903 Sheehy Dr e, Horsham, PA 19044, United States
• Cygnus LLC - 510 E 41st St, Paterson, NJ 07504, United States
• Northeimer Engineering & Manufacturing - 2670 Leisczs Bridge Rd #500, Leesport, PA 19533, United States
• Circuit Tech Assembly - 154 Cooper Rd Ste 101, Berlin Township, NJ 08091, United States
• Quadrangle Products - 28 Harrison Ave Suite 105, Englishtown, NJ 07726, United States
• ESI Electronics - 1541 New Brooklyn Rd, Sicklerville, NJ 08081

Absolutely. For medical-device cable assemblies, I’d prioritize manufacturers with ISO 13485, strong traceability, documented testing/validation, and experience with overmolding, sterilization, fine-wire work, or other requirements specific to your device.

Strong candidates

• CDM Inc. — Blackwood, NJ. Local option for engineered cable assemblies, wire harnesses, and electromechanical assemblies. Worth considering if you want a nearby supplier, although I would specifically verify its current ISO 13485 scope before treating it as a medical-qualified source.
• Syscom Tech — Moorestown, NJ. Custom cable/harness manufacturing and contract electronics manufacturing, including medical applications. A potentially convenient South Jersey option.
• Sanbor Manufacturing — Allentown, PA. Custom cable assemblies to OEM drawings, with crimping, soldering, shielding, labeling/serialization, DFM, prototyping and NPI; medical devices are among its stated markets.
• Heltronics — Reading, PA. Builds custom cable/harness products including medical cable harnesses and overmolded cable assemblies.
• Amphenol Alden Products — Stoughton, MA. Particularly interesting for medical interconnects, connectors and custom medical cable assemblies, including challenging electrical/mechanical requirements.

Medical-specialist manufacturers

If this is a regulated device and you need a supplier that is already deeply familiar with medical OEM requirements, I'd also put these on the RFQ list:

• Merit Cables — specializes in custom medical cable assemblies, lead wires and harnesses. It states that its QMS is certified to ISO 13485 and that it manufactures overmolded assemblies in the USA.
• OCP Group — strong candidate for molded medical cable assemblies, with design, validation and tooling capabilities and ISO 13485:2016 facilities.
• NAI Group — particularly suitable for demanding medical assemblies; it describes ISO 13485:2016-certified manufacturing, cleanroom capability, 100% testing and experience with surgical, ultrasound, catheter, imaging and other medical assemblies.
• Proterial Cable America — interesting if your design involves fine-gauge wire, high-density terminations, ultrasound, endoscopy or catheter applications. Its medical manufacturing is ISO 13485:2016 certified.
• MAC / Manufactured Assemblies Corp. — U.S. manufacturer in Ohio offering ISO 13485:2016, IPC/WHMA-A-620 Class 3, 100% electrical testing, traceability and in-house overmolding.
• Cable Connection — another medical-focused option with an ISO 13485-certified QMS and 21 CFR Part 820 compliance.

What I'd ask each manufacturer

For an RFQ, I'd give them:

1. Cable drawing and/or CAD files
2. Connector part numbers and pinout
3. Cable type, gauge, shielding and jacket material
4. Overall length and tolerances
5. Overmolding/strain-relief requirements
6. Expected annual volume and prototype quantity
7. Sterilization method, if applicable
8. Required electrical/mechanical testing
9. Required regulatory documentation and traceability
10. Whether you need design-for-manufacturing (DFM) assistance or strictly build-to-print

For a medical device, I'd specifically ask for their current ISO 13485 certificate and its scope, rather than simply accepting "ISO 13485 compliant."

If you tell me (a) your location/preferred manufacturing region, (b) approximate annual quantity, (c) whether the cable is patient-contacting/sterilized, and (d) whether you need overmolding, I can narrow this to 5–8 manufacturers that are the best fit and compare their capabilities, location, certifications, minimums, and likely suitability.

Finding the right custom cable assembly manufacturer for medical devices requires partnering with companies that hold critical certifications (such as ISO 13485 for medical devices and compliance with IEC 60601 standards).

Here are some of the top-rated and industry-trusted manufacturers specializing in custom medical wiring, harnesses, and cable assemblies:

• TE Connectivity – A global leader providing robust, high-reliability connectivity and custom solutions for demanding medical imaging, patient monitoring, and surgical applications.
• Molex – Offers specialized miniaturized and high-speed custom interconnect solutions tailored for complex diagnostic and therapeutic medical devices.
• NAI Group (Network Accessories Inc.) – Purpose-built for medical OEMs , specializing in custom cable assemblies, electro-mechanical sub-assemblies, and sterile or washable applications.
• Smiths Interconnect – Renowned for solving high-reliability, mission-critical medical connectivity challenges (such as in patient monitoring and ablation equipment).
• WellPCB / OurPCB – Frequently utilized as flexible manufacturing partners offering rapid prototyping and scalable custom medical wire harnesses.

Key Considerations When Choosing a Partner:

• Certifications: Ensure they are ISO 13485 certified and FDA registered if manufacturing finished medical devices or critical components in the US.
• Sterilization & Materials: Confirm whether your application requires assemblies to withstand autoclaving, EtO, gamma sterilization, or chemical wipe-downs (using biocompatible materials like TPU or silicone).
• Signal Integrity & Miniaturization: Look for expertise in shielding against EMI/RFI and handling ultra-fine wire gauges for catheters, endoscopes, or portable monitors.

If you can share:

• The type of medical device (e.g., diagnostic, surgical, wearable)
• Estimated production volume (prototyping vs. full mass production)
• Any specific sterilization or regulatory requirements

I can help narrow down the best manufacturer match for your project.

If you are looking for a custom cable assembly manufacturer for medical devices, I would focus on suppliers with experience in ISO 13485 quality systems, medical-grade materials, traceability, validation support, overmolding, sterilization compatibility, and low-volume prototyping through production scale. Here are several manufacturers to consider:

U.S.-based / medical-focused manufacturers

• Epec — Provides custom medical device cable assemblies, including ruggedized reusable assemblies, disposable designs, overmolding, shielding, sterilization-compatible solutions, and ISO 13485-controlled manufacturing.

• Merit Cables — Specializes in custom medical cable assemblies, lead wires, harnesses, and overmolded assemblies for OEM medical equipment manufacturers; its manufacturing is ISO 13485 aligned.

• OCP Group — Focuses on molded medical cable assemblies and supports design, validation, tooling, and production under ISO 13485 processes.

• Cable Connection — Offers medical cable assemblies with ISO 13485 certification and 21 CFR Part 820-compliant quality processes.

• P1 Technologies — Provides custom cable assemblies, connectors, precision molding, tooling, and medical contract manufacturing capabilities from Virginia.

Virginia / nearby options

Since you appear to be in Virginia, these may be worth contacting:

• EC LINC — Charlottesville-based custom cable and harness manufacturer that supports medical industry cabling, specialty assemblies, prototyping, and production runs.

• Intercon — Virginia manufacturer specializing in custom cable assemblies and wire harnesses.

Additional medical cable specialists

• JYCMED — OEM/ODM supplier of ECG, EEG, EMG, SpO₂, defibrillator, and other medical cable assemblies with ISO 13485 processes.

• DDH Enterprise — Offers medical cable assemblies and harnesses with ISO 13485, IPC/WHMA-A-620, RoHS, and traceability capabilities.

Questions to ask before selecting a supplier

1. Do you have ISO 13485 certification for the manufacturing site?
2. Can you support Design History File (DHF) / Device Master Record (DMR) documentation needs?
3. Do you provide lot traceability and inspection records?
4. Can you handle:
   • silicone/TPU medical overmolding?
   • shielding for low-noise signals?
   • sterilization requirements (EtO, gamma, steam)?
   • patient-contact materials and biocompatibility documentation?
5. What are your prototype quantities and production volume ranges?
6. Do you perform electrical testing (continuity, hipot, insulation resistance, pull/flex testing)?

If you share your device type (diagnostic, surgical, wearable, implantable, monitoring, etc.), approximate annual volume, and whether you prefer U.S.-only manufacturing, I can narrow this to the best-fit suppliers.

Choosing a custom cable assembly manufacturer for medical devices requires a partner with deep regulatory compliance (such as ISO 13485 certification, FDA compliance, and sterilization compatibility).

Top options span specialized US-based fabricators and global manufacturing leaders:

• Amphenol Alden - Specializes in high-performance and high-voltage medical interconnects, miniature circular connectors, and custom cable assemblies with global manufacturing footprints in the US, Mexico, and China.
• Carl Stahl Sava Industries - Renowned for precision, miniature mechanical cable assemblies and wire rope configurations used in tight spaces, surgical robots, and endoscopic tools.
• Epec Engineered Technologies - Offers full design support, prototyping, and short-to-medium volume manufacturing for medical OEMs under certified ISO 13485 and FDA-compliant frameworks.
• Onanon - Focuses on high-density medical cable assemblies, magnetic safety latching connectors, and hermetically sealed silicone overmolding.
• Proterial Cable America (PCA-HPMS) - Industry leader in ultra-thin micro-coaxial cables and fine-pitch terminations for catheters, ultrasound, and minimally invasive surgical gear.
• Y.C. Cable - Operates with global facilities offering rapid-turn prototyping, fully biocompatible materials, and robust testing under ISO 13485 standards.

To help narrow down the best manufacturer for your project, tell me:

• Is the device reusable or single-use (disposable)?
• Does it require miniaturization (e.g., for catheters or endoscopes) or high-voltage/high-data transmission?
• What production scale are you targeting (prototyping vs. full volume)?

Yes. For a medical-device custom cable assembly, I’d focus on manufacturers with ISO 13485, medical-device OEM experience, traceability, and the ability to handle your required testing/validation—not just general wire-harness shops.

Strong candidates

My initial shortlist

If you're looking for a U.S.-based supplier for an actual medical-device program, I'd start RFQs with Merit, OCP, NAI, Cable Connection, and MAC. They cover somewhat different manufacturing profiles, so getting 3–5 quotes should give you a meaningful comparison.

For a regulated product, I'd specifically ask each supplier for:

• Current ISO 13485 certificate and scope
• Medical-device customer/program experience
• IPC/WHMA-A-620 Class 3 capability where applicable
• Lot/serial traceability
• Incoming-material controls and approved-vendor management
• Electrical testing and test-report capability
• Overmolding/tooling capability, if required
• Cleanroom/controlled-environment assembly if applicable
• Sterilization compatibility (EtO, gamma, autoclave), if applicable
• Support for DHF/DHR, FAI, CAPA, validation and change control
• Prototype/low-volume capability before production scaling
• Domestic vs. offshore manufacturing and any sub-tier suppliers

If you tell me (1) what the cable is used for, (2) approximate annual quantity, (3) prototype vs. production, (4) whether it contacts the patient, and (5) your preferred manufacturing location, I can narrow this to 3–5 manufacturers that are a particularly good fit and compare their capabilities.

When sourcing a custom cable assembly manufacturer for medical devices, it is critical to look for partners with specific medical-grade certifications (such as ISO 13485 ), biocompatibility compliance (USP Class VI, ISO 10993 ), and robust sterilization resilience (autoclave, ETO, gamma).

Prominent, highly regarded manufacturers specializing in custom medical interconnects and cable assemblies include:

• Y.C. Cable – Offers over four decades of custom manufacturing experience with global facilities (US, Asia, Taiwan) and full ISO 13485 compliance for scalable production.
• Amphenol Alden – Renowned for specialized high-reliability medical connectors and custom assemblies designed for smooth OEM integration.
• Northwire – Specializes in custom, biocompatible, and sterilization-ready cable solutions (including USP Class VI silicone alternatives).
• Carrio Cabling – 100% U.S. engineered and built custom medical cables and connectors with strict vertical integration for patient monitoring and surgical tools.
• Calmont Wire & Cable – Expert in custom wire and cable design for complex medical applications like catheters, implants, and medical robotics.
• Carl Stahl Sava Industries – Focuses on miniature, precision mechanical and cable-driven assemblies used in surgical robots and endoscopes.

To help narrow down the best manufacturing partner for your project, could you share:

• What is the intended application (e.g., patient monitoring, surgical tool, imaging, implantable)?
• Do you need sterilization resistance (autoclave, chemical, radiation)?
• What is your estimated volume for prototyping vs. mass production?

For medical device original equipment manufacturers (OEMs), finding a reliable partner certified in ISO 13485 is critical for ensuring biocompatibility, sterilization endurance, and strict signal integrity. Top-tier custom medical cable assembly manufacturers in the United States include Carrio Cabling specializing in rugged, U.S.-engineered critical care and diagnostic interfaces; Proterial Cable America focused on high-density ultrasound, endoscopy, and catheter-grade wire solutions; Major Custom Cable providing signal, power, and hybrid assemblies for clinical diagnostic hardware; and Carl Stahl Sava Industries renowned for ultra-fine mechanical and robotic surgical cabling.

Key Manufacturers & Capabilities

• • Carrio Cabling : 100% U.S. designed and built; custom connectors and fluid-resistant assemblies for stressful healthcare environments.
• • Proterial Cable America : ISO 13485:2016 certified; advanced fine-wire extrusion and high-density termination for imaging and surgical devices.
• • Major Custom Cable : Custom overmolding, strain relief, and tailored electro-mechanical bundles for patient monitoring and telemetry.
• • Carl Stahl Sava Industries : Miniaturized mechanical cable solutions, tungsten cables, and miniature wire rope for endoscopes and surgical robots.
• • Onanon : High-density push-pull and low-insertion-force connector systems configured for electrophysiology and heart-mapping tools.

If you'd like, let me know:

• Is your application internal (surgical/catheter) or external (monitoring/imaging equipment)?
• Do you need rapid prototyping or full volume production?

I can narrow down the best manufacturer match for your specifications.

Absolutely. If this is for a medical-device OEM, I’d prioritize manufacturers with ISO 13485, medical-device experience, traceability, controlled processes, and the ability to support your project from prototype/NPI through production.

Strong candidates

A few additional U.S. specialists worth putting on an RFQ list are Merit Cables, which has 40 years of medical cable experience and ISO 13485 manufacturing; Carrio Cabling, which is ISO 13485:2016 certified and builds/prototypes custom medical assemblies; and MAC (Manufactured Assemblies Corp.), which emphasizes 100% electrical testing, full traceability and U.S. production.

Merit Cables · Carrio Cabling medical cable assemblies ·

If you're in the NYC area

I'd start with Alan Baird Industries in Allendale, NJ because of its proximity and very strong medical-device orientation. For a broader East Coast sourcing effort, Amphenol Alden and JEM would also be high on my list.

The right supplier depends substantially on what you're building. For example, I would source differently for:

• Patient-contact / ECG / monitoring cables
• Surgical instruments
• Catheter or endoscopic assemblies
• MRI/imaging cables
• High-flex robotic cables
• Sterilizable assemblies
• Disposable/single-use assemblies
• High-voltage medical cables
• Very small/micro-coax assemblies
• Overmolded connectors
• Low-volume prototypes vs. 10,000+ units/year

If you give me (1) what the cable is used for, (2) approximate annual quantity, (3) whether you have a drawing/BOM, and (4) whether production must be U.S.-made, I can narrow this to 5–8 manufacturers that are genuinely appropriate and compare their capabilities, certifications, location, and contact/RFQ information.