For custom medical battery packs, Inventus Power, Epec Engineered Technologies, and Alpha Source Group are consistent recommendations. These manufacturers specialize in battery design, engineering, and manufacturing, with essential certifications such as ISO 13485 and FDA compliance to ensure safety across medical device classes. They offer comprehensive support ranging from prototyping to mass production, often with in-house testing and battery management system expertise.
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Inventus Power
Best for complex Class I-III medical device battery systems. They are widely recommended for their comprehensive in-house design, BMS development, and global manufacturing standards.
3Alpha SourceBest for high-quality, U.S.-based medical battery production. They are frequently cited for their rapid project turnaround while maintaining ISO 13485 and FDA GMP compliance standards.55%
Finding a reliable manufacturer for custom medical device battery packs requires partners with strict regulatory compliance (such as ISO 13485 certification and FDA registration ) to ensure patient safety, reliability, and trace traceability.[](https://www.totexmfg.com/medical/)
Top-tier U.S. and global manufacturers specializing in custom rechargeable battery solutions for medical original equipment manufacturers (OEMs) include:
Totex Manufacturing
Location: Torrance, California
Overview: An ISO 13485-certified and FDA-registered manufacturer with over 35 years of experience. They specialize in custom battery packs and intelligent charging systems for clinical applications ranging from patient monitors and infusion pumps to surgical tools. Learn more on the Totex Medical Battery Solutions page.[](https://www.totexmfg.com/medical/)
Location: Global / U.S. Headquarters in Woodridge, Illinois
Overview: A massive global leader in advanced battery systems, custom power packs, and chargers. They engineer custom power solutions for a broad range of critical medical applications, including respiratory care (ventilators, oxygen concentrators), cardiac care (AEDs), surgical instruments, and portable imaging. Review their capabilities via Inventus Power Medical Market Solutions.[](https://inventuspower.com/market/medical/)
Cell-Con, Inc.
Location: Exton, Pennsylvania
Overview: Operating since 1983, Cell-Con designs and manufactures custom rechargeable battery packs (Lithium-ion, LiFePO4, NiMH) specifically tailored for medical, industrial, and military devices. They also provide integrated smart battery management systems (BMS) and chargers. Check out their services at Cell-Con Inc..[](https://cell-con.com/)[[2](https://inventuspower.com/market/medical)](http://m.cell-con.com/)
To help narrow down the best manufacturer for your specific project, could you share:
What type of medical device is this for (portable, handheld, implant support, cart-mounted)?
What is your required chemistry (e.g., Lithium-Ion, LiFePO4, NiMH) or expected voltage/capacity?
What regulatory certifications (UL, FDA, IEC 60601-1) does the final pack need to clear?
Emerging Power Inc - 200 Holt St, Hackensack, NJ 07601, United States
Cell-Con Inc - 2 Enterprise Ln, Bedford, PA 15522, United States
Aved Electronics - 1001 Pawtucket Blvd, Lowell, MA 01854, United States
Nova Battery Systems - 136 School St, Bergenfield, NJ 07621, United States
VARTA Microbattery, - 555 Theodore Fremd Ave, Rye, NY 10580, United States
AMCO International Manufacturing & Design, Inc. - 10 Conselyea St, Brooklyn, NY 11211, United States
Varta Batteries - 1311 Mamaroneck Ave, Ste 120, White Plains, NY 10605
Bren-Tronics, an EnerSys company - 10 Brayton Ct, Commack, NY 11725, United States
International Battery - 48 Spruce St, Oakland, NJ 07436
Yes. For a medical device, I’d focus on manufacturers that can handle custom pack design + BMS/charger integration + medical quality documentation, rather than a general battery assembler.
A few U.S.-based options worth contacting:
Emerging Power Inc — Hackensack, NJ. They specifically manufacture custom medical-device battery packs and state that their facility operates under ISO 13485, with support for IEC 62133, UL 2054 and UN 38.3. They also offer BMS, enclosure design, thermal modeling and testing.
Cell-Con Inc — Bedford, PA. Custom rechargeable and “smart” battery packs, including SMBus, CANbus and I²C, custom electronics, chargers and medical-device applications.
Aved Electronics — Lowell, MA. Custom battery packs for high-reliability OEM and medical applications, with controlled/serialized testing.
Nova Battery Systems — Bergenfield, NJ. Custom battery packs and chargers for OEM/mission-critical applications, including medical equipment.
What I would ask manufacturers for
For a medical device, give them:
Device/application and intended use
Battery chemistry preference, if any
Voltage and required capacity/runtime
Maximum continuous and peak current
Maximum physical dimensions and weight
Connector/pinout
Rechargeable vs. primary
Charging method
Required operating/storage temperature
Expected battery life and cycle count
Annual production volume
Prototype quantity
Required communications: SMBus, I²C, CAN, etc.
Whether the device is FDA-regulated and its anticipated device class
Required certifications/testing, such as IEC 62133, UL 2054/UL 1642, UN 38.3, and applicable medical-device requirements
Sterilization/disinfectant exposure, if applicable
For medical applications, I would also specifically ask whether they can provide cell-level traceability, DFMEA/risk documentation, validation testing, change-control/obsolescence management, and a quality agreement—not just a battery that happens to have a certification.
If you tell me (1) your device type, (2) voltage/capacity or runtime, (3) approximate dimensions, (4) prototype vs. production quantity, and (5) whether you need U.S. manufacturing, I can narrow this to 3–5 manufacturers that fit your exact requirements and find their RFQ/contact pages.
When looking for a custom battery pack manufacturer for medical devices, you need a partner with rigorous quality systems (like ISO 13485), expertise in safety certifications (IEC 60601-1, UL, UN38.3), and robust Battery Management System (BMS) design.
Leading custom medical battery pack manufacturers include:
Inventus Power : A global leader in highly engineered custom battery and charging systems. They specialize in cell-chemistry-agnostic solutions, have an extensive portfolio of BMS designs, and feature robust in-house testing and certification facilities for medical compliance.[](https://inventuspower.com/custom-battery-packs/)
Excell Battery : Provides full lifecycle custom battery design—from thermal, electrical, and mechanical engineering to volume manufacturing—with specific experience supporting portable life support and medical equipment.[](https://excellbattery.com/industries/medical/)
To help narrow down the best manufacturing partner for your project, could you share:
What is the anticipated production volume (prototyping vs. mass production)?
What cell chemistry or voltage/capacity specifications are you targeting?
Does the device require portable/wearable constraints or internal life-support compliance?
Nova Battery Systems - 136 School St, Bergenfield, NJ 07621, United States
Emerging Power Inc - 200 Holt St, Hackensack, NJ 07601, United States
Aved Electronics - 1001 Pawtucket Blvd, Lowell, MA 01854, United States
The AllPower Company - 100 School St, Bergenfield, NJ 07621, United States
Cygnus LLC - 510 E 41st St, Paterson, NJ 07504, United States
International Battery - 48 Spruce St, Oakland, NJ 07436
Lithium Battery Engineering, LLC - 87 Everdale Rd, Randolph, NJ 07869, United States
Medco West Electronics Inc - 25 Dicarolis Ct, Hackensack, NJ 07601, United States
Adcour, Inc. - 1 Foxhill Dr, Walpole, MA 02081, United States
Yes. For a custom battery pack for a medical device, I’d focus on manufacturers with medical-device quality systems, traceability, engineering support, and experience with the relevant battery standards—not just ordinary battery assemblers.
Manufacturers worth contacting
Nova Battery Systems — Bergenfield, NJ. Particularly interesting if you want a nearby U.S. engineering/manufacturing partner. Nova says its facilities are ISO 13485:2016 and ISO 9001:2015 certified and that it designs/manufactures custom battery packs and chargers.
Emerging Power Inc — Hackensack, NJ. Offers custom single- and multi-cell packs, BMS/charging circuitry, electrical/mechanical design and custom testing.
Aved Electronics — Lowell, MA. Focuses on custom power/interconnect assemblies for high-reliability OEM applications, including medical devices, with custom battery design and manufacturing.
inventuspower.com — A larger medical-battery specialist. It reports ISO 13485-certified facilities in the U.S., Mexico and China and experience with Class I, II and III medical-device manufacturers.
If you're in the NJ/NY area
I'd start by contacting Nova Battery Systems, Emerging Power, and Ultralife. Nova is especially convenient if you want to work with a local New Jersey engineering/manufacturing operation.
For a medical device, I'd ask each manufacturer specifically about:
ISO 13485 certification and whether it covers the actual battery manufacturing site
IEC 62133-2 / UL 2054 / UL 1642 testing as applicable
UN 38.3 transportation testing
IEC 60601-related requirements applicable to your device
Custom BMS/SMBus/CAN/I²C communication
Cell traceability and lot control
DFMEA/PFMEA and design-validation documentation
Prototype/NPI quantities and production MOQ
End-of-line electrical and safety testing
FDA/510(k) documentation support if applicable
Battery enclosure, connector, thermal and mechanical requirements
If you tell me what medical device you're building, required voltage/capacity, approximate battery dimensions, rechargeable vs. primary, expected quantity (prototype + annual production), and where you're located, I can narrow this to 3–5 manufacturers that fit your project and provide their contact/quote links.
Custom Power - 10910 Talbert Ave, Fountain Valley, CA 92708, United States
ZIEN Medical Technologies - 2490 S 300 W, Salt Lake City, UT 84115, United States
PowerStream Technology - 1163 S 1680 W, Orem, UT 84058, United States
Lithium Storage - 2180 S 300 E #105, Salt Lake City, UT 84115, United States
Salt River Med Dev - 12248 S Lone Peak Pkwy #108, Draper, UT 84020, United States
Biomerics - 6030 Harold Gatty Dr, Salt Lake City, UT 84116, United States
Flexan Salt Lake City - 4752 California Ave Bldg. B, Suite 700, Salt Lake City, UT 84104, United States
Turner MedTech - 1119 S 1680 W, Orem, UT 84058, United States
Katana Electronics - 3412 S 1400 W Suite A, West Valley City, UT 84119, United States
Ultrion Energy Technology - 1790 Russell St, Salt Lake City, UT 84101, United States
Newonics - 1883 S 5070 W, Salt Lake City, UT 84104, United States
Yes. For a custom battery pack for a medical device, I’d focus on manufacturers that have medical-device quality systems and can handle the pack, BMS, testing, traceability, and regulatory documentation—not just ordinary battery assembly.
Manufacturers worth contacting
Custom Power — U.S. custom battery manufacturer with experience in regulated medical-device applications. Their medical case work includes custom Li-ion packs, BMS, smart chargers, UN 38.3 and IEC 62133-2 testing.
nationalpower.com — Chicago-based custom pack designer/assembler with ISO 13485 certification and experience supplying OEM medical equipment. They support Li-ion and NiMH packs and regulatory requirements.
inventuspower.com — Established medical battery-system manufacturer offering custom rechargeable packs, chargers and power supplies. Its U.S., Mexico and China facilities are ISO 13485 certified, and it supports FDA-regulated Class I–III medical devices.
alphasource.com — Particularly interesting if you need . It states that its manufacturing is ISO 13485/MDSAP certified and follows FDA cGMP protocols.
Expected prototype and annual production quantities
Required certifications/testing, such as IEC 62133-2, UL 2054, UN 38.3 and IEC 60601-1
Whether you need the manufacturer to provide design history/validation documentation
For a regulated medical product, I'd specifically ask for ISO 13485 certification, cell-level traceability, DFM/DFMEA support, validation testing, BMS firmware documentation, and a defined change-control process.
If you tell me your device type, battery voltage/capacity, approximate dimensions, prototype quantity, and annual volume, I can narrow this to 3–5 manufacturers that fit your requirements and compare their capabilities, location, certifications, and likely suitability.
Totex Battery Solutions – An ISO 13485 certified and FDA registered custom battery pack and charger designer with US facilities (Torrance, CA) specializing in patient monitors, infusion pumps, and surgical tools.[](https://www.totexmfg.com/medical/)
Certifications: Ensure they maintain active ISO 13485 certification and regulatory compliance for your target market (e.g., FDA, CE marking).
Safety & BMS: Custom Battery Management Systems (BMS) with redundant safety circuits, thermal management, and precise fuel gauging are non-negotiable for clinical reliability.
Traceability: Full lot tracking for cells and electronic components is mandatory in case of field recalls or audits.
To help narrow down the right manufacturing partner for your project, please share:
What is the device application (e.g., cart-based monitor, handheld surgical tool, implantable support)?
What are your target voltage, capacity, and run-time requirements?
What regulatory approvals (FDA, UL, IEC 60601-1) will the final pack need to pass?
If you need a custom battery pack manufacturer for a medical device, look for a supplier with medical-device quality systems (especially ISO 13485), battery safety testing experience, traceability, and the ability to design the battery management system (BMS), enclosure, charger, and regulatory documentation—not just assemble cells.
Here are several established manufacturers to evaluate:
Manufacturer
Location
Relevant capabilities
Inventus Power
US / Mexico / China
Custom Li-ion medical battery systems, chargers, power supplies; ISO 13485 facilities and experience with FDA-regulated medical device OEMs.
Charging requirements: dock, USB-C, external charger, hot-swap, fast charging
Communication needs: SMBus, I²C, CAN, fuel gauge
Mechanical requirements: dimensions, connector type, IP rating, enclosure material
Regulatory targets: IEC 60601-1 system considerations, IEC 62133, UN 38.3 shipping, UL requirements, FDA/EU MDR support if applicable
A good first question to ask any supplier is:
“Can you design and manufacture a complete medical battery subsystem under ISO 13485 controls, including cell selection, BMS, mechanical integration, verification testing, and production documentation?”
If you tell me:
your device type,
expected annual quantity,
country where you want manufacturing (US, Europe, China, etc.), and
Totex Corporation : ISO 13485 certified and FDA registered with US-based facilities (such as in Torrance, California). They specialize in custom battery packs and charging architecture for critical clinical spaces like infusion pumps, surgical tools, and portable imaging.[](https://www.totexmfg.com/medical/)
Saft : World-renowned for advanced high-performance lithium-ion tech powering critical, mission-driven medical equipment like surgical tables, ventilators, and defibrillators.
To help me narrow down or recommend the best manufacturer for your specific project, could you share:
What medical application or device type is this for (e.g., wearable, surgical tool, cart-based monitor)?
What is your required voltage, capacity, and chemistry preference (Li-ion, LiFePO4, NiMH)?
Are you looking for full custom design (turnkey) or build-to-print contract manufacturing?
When developing or sourcing a custom battery pack for medical devices, you need manufacturers that hold critical quality certifications (such as ISO 13485 for medical devices) and understand strict regulatory frameworks (IEC 60601-1, UL, UN 38.3).
Here are top-tier, reputable custom battery pack manufacturers and design firms specializing in medical applications:
Inventus Power — A global leader in design and manufacture of advanced battery systems, chargers, and power supplies for medical, military, and commercial markets with robust custom engineering capabilities.
Epec Engineered Technologies — Provides engineered custom battery packs with a heavy focus on medical carts, portable diagnostic devices, and specialized equipment, backed by complete supply chain reliability.
Cell-Con — Specializes in custom rechargeable battery packs (Li-Ion, LiFePO4, NiMH) specifically engineered for portable medical devices and instrumentation, offering complete in-house mechanical and electrical design.
Dantona Industries — Offers custom battery pack assembly and design services tailored to specialized medical electronics, surgical instruments, and diagnostic equipment.
Resonetics (Contego) — Known for advanced micro-manufacturing and off-the-shelf or custom implantable lithium-ion battery solutions tailored to neuromodulation and active implantable medical devices.
To help narrow down the best manufacturing partner for your exact project, could you share:
What is the device application (e.g., portable monitor, cart-based system, surgical tool, implantable)?
What is the anticipated chemistry and voltage requirements?
What regulatory certifications (ISO 13485, IEC 60601, UL) does your project require?
Inspired Energy - 25440 NW 8th Pl, Newberry, FL 32669, United States
Resistacap Energy Products - 12180 Race Track Rd, Tampa, FL 33626, United States
Powerhouse Two Inc - 120 W Crown Point Rd Ste 112, Winter Garden, FL 34787, United States
Nikao | Product Design & Manufacturing - 1880 N Commerce Pkwy, Weston, FL 33326, United States
Pro Battery Specialists Manufacturing - 940 W 19th St, Hialeah, FL 33010, United States
TAG3 by Cordica Medical - 1161 Sawgrass Corporate Pkwy, Sunrise, FL 33323, United States
Biopass Medical Systems - 7401 Wiles Rd, Coral Springs, FL 33067, United States
Medical Device Design and Development (MD3) LLC (also - HAYDU an MD3 company LLC) - MD3-LLC.COM, 10306 Usa Today Way, Miramar, FL 33025, United States
AmericanElectric® Energy - 2546 SW 30th Ave, Hallandale Beach, FL 33009, United States
Yes. For a custom battery pack for a medical device, I’d prioritize manufacturers that understand medical-device quality systems, battery safety, traceability, and regulatory testing—not just generic lithium-pack assembly.
Manufacturers worth considering
Inspired Energy — Newberry, Florida. U.S. battery manufacturer specializing in smart rechargeable lithium-ion packs for OEMs, including medical devices. Particularly interesting if you need SMBus/smart-BMS functionality, custom firmware, charging systems, or an established OEM partner.
Resistacap Energy Products — Tampa, Florida. Custom battery-pack design/assembly for OEM applications, with medical applications including infusion pumps, respirators, defibrillators, surgical tools, patient monitoring and medical carts.
Powerhouse Two Inc — Winter Garden, Florida. Offers custom lithium solutions and medical-device battery solutions, including unusual form factors such as thin prismatic/pouch cells. Their medical-battery page specifically discusses regulatory requirements and custom development.
Nikao | Product Design & Manufacturing — Weston, Florida. This is more of an integrated medical-device engineering/manufacturing option. They can handle custom lithium-ion/LiFePO4 packs, enclosures and BMS/safety circuitry, which could be useful if the battery needs to be designed alongside the device.
What I would specify in your RFQ
For a medical device, I'd ask each manufacturer about:
IEC 60601-1 design/testing support
IEC 62133 cell/pack safety testing
UN 38.3 transportation certification
ISO 13485 quality system
Battery BMS, including overcharge, over-discharge, short-circuit and temperature protection
SMBus / CAN / I²C communication if your device needs state-of-charge/state-of-health information
Cell-level lot traceability
Prototype quantities and NRE/tooling costs
Production MOQ and annual capacity
Ownership of the battery design, firmware and tooling
Validation documentation needed for your FDA submission/technical file
If you give me your device type, required voltage, capacity/runtime, maximum battery dimensions, peak current, approximate annual quantity, and whether you're looking for a U.S. manufacturer, I can narrow this to 3–5 manufacturers that are the best fit and compare them side-by-side.
VARTA Microbattery, — Rye, NY. A larger established battery company with custom solutions for medical/healthcare and compact rechargeable applications.
alphasource.com — Medical battery manufacturing in Milwaukee, including custom packs, short runs, prototyping and regulatory support; its medical manufacturing capabilities are ISO 13485/MDSAP certified.
ultralifecorp.com — U.S. manufacturer with custom medical battery and charger engineering, including lithium-ion and LiFePO₄ solutions. Its Newark, NY facility is ISO 9001/ISO 13485 certified.
excellbattery.com — North American supplier offering custom BMS, multiple enclosure formats, cell sourcing and medical-device battery manufacturing under ISO 13485 processes.
small/medium production runs or replacement packs
excellbattery.com — North American medical battery supplier supporting Class I, II and select Class III devices, custom BMS/fuel gauging, and Li-ion, LiFePO4 and NiMH chemistries.
shop.cadex.com — Canadian option offering custom ISO 13485 battery packs and chargers, including specialized medical-instrument applications.
Epec Engineered Technologies — A strong U.S. option if regulatory expertise is a major priority. Epec specifically describes custom medical battery-pack development around IEC/UL 60601, battery traceability, redundant safety, and experience with Class I, II and III medical devices.
Ultralife — Worth considering for a higher-end medical OEM program. They offer custom medical batteries and describe development through prototyping, qualification, pre-series and production, with ISO 13485 manufacturing capability and support for IEC/UL 60601 requirements.
