Medical Devices.
IEC 60601-compliant cells with ISO 13485 traceability.
Built for audited supply chains.
Our medical line runs on a dedicated ISO 13485-aligned production cell, with full batch traceability, DHF-ready documentation and biocompatible casing options. We support device makers through 510(k), CE MDR and NMPA submissions — and we hold the records for 10 years so audit requests in 2034 still resolve cleanly.
ISO 13485 Alignment
Dedicated clean-room line, document control, CAPA process, design-history-file (DHF) support per ISO 13485:2016. Harmonised with the FDA 2024 QMSR.
Biocompatible Materials
USP Class VI casings and adhesives for skin-contact wearables. ISO 10993-5 cytotoxicity and -10 irritation data on file.
Low Self-Discharge
< 2% per month at 25 °C, < 5% at 40 °C. Critical for devices sitting on hospital shelves or distributor warehouses for 12+ months before use.
5-Year Shelf Life
Up to 5 years with controlled SOC (40%) and humidity (< 60% RH). Cell capacity at year 5 ≥ 85% of fresh.
Sterilization Compatible
EtO-stable formulations qualified through 3 cycles. Gamma compatibility up to 25 kGy on request (separate cell variant).
Serial-Level Traceability
Every cell links to its formation curve, materials lot, OCV/IR, and test data — retrievable 10 years later via batch ID.
One platform per device class.
Medical devices split cleanly into two cell-architecture buckets — and the chemistry, packaging and BMS choices look very different in each.
Wearable monitors and reusable handhelds.
Rechargeable Li-Po pouch (single-cell or 2S smart pack) with full BMS, fuel gauging, and a 500 to 1,500 cycle life target. Hearing aids, ECG monitors, Holter recorders, infusion pumps and portable ultrasound platforms run on this architecture. Cells ship from 25 mAh (RIC hearing aid) up to 12 Ah (point-of-care ultrasound).
BMS topology is typically SBS 1.1 smart battery when the host system needs SoC reporting and predicted runtime — both common requirements for medical UI.
Single-use sterile patches and implant adjacents.
Single-use Li-MnO₂ or thin Li-Po pouches optimised for shelf life and EtO sterilization rather than cycle count. CGM patches, single-use defibrillator pads, drug-delivery patches and post-surgical monitoring patches use this architecture. Capacity 40 to 120 mAh, runtime 7 to 14 days.
Cell mass is dominated by the requirement to survive a single EtO sterilization cycle without electrolyte vapour pressure rupturing the pouch — a different optimisation than rechargeable design.
What we power today.
| Device | Cell Type | Capacity | Notes |
|---|---|---|---|
| Hearing aid (RIC) | Li-ion coin | 25 – 100 mAh | 300+ cycles, 14 h runtime |
| CGM / blood-glucose patch | Single-use LiPo | 40 – 120 mAh | 14-day life, sterile pack |
| Wearable ECG / Holter | LiPo pouch | 250 – 600 mAh | 7-day continuous monitoring |
| Insulin / infusion pump | Li-Po pouch (smart pack) | 800 – 1,500 mAh | Alarm redundancy, low SD, SBS 1.1 |
| Portable ultrasound / POC | Smart pack (SBS 1.1) | 3 – 12 Ah | SMBus, hot-swap, 1500+ cycles |
| Defibrillator AED battery | Li-MnO₂ primary | 10 – 28 Ah | 5-yr standby, 200+ shocks |
What medical OEMs ask before they commit.
Is ISO 13485 enough for FDA submission?
Effectively yes by 2026. The 2024 FDA QMSR explicitly harmonises 21 CFR 820 with ISO 13485:2016, so a compliant ISO 13485 line meets both. We add the documentation hooks 21 CFR 820 still expects — design-history-file structure, complaint handling, CAPA traceability — so customers can bind our cell DHF directly into their device DHF without translation.
Do you provide IEC 60601 leakage data?
Yes. Cell-level dielectric strength and isolation testing per IEC 62133-2; device-level patient leakage current measurement is the customer's responsibility (it depends on the patient interface, which we don't make), but we provide the cell-side isolation data their EMC lab needs to integrate. Patient leakage limits (≤ 100 µA normal, ≤ 500 µA single fault) are met when the cell is integrated correctly behind the customer's medical-grade isolation.
Can I sterilize my device after the battery is installed?
Single EtO cycle (54 °C, 6 hours, 600 mg/L) is fine for our standard Li-Po with ≤ 2% capacity loss if pre-charged to 30% SOC. Repeated EtO or gamma sterilization above 25 kGy needs the dedicated sterilization-grade variant. We qualify each new cell SKU through 3 EtO cycles before release.
How long are records retained?
10 years minimum per ISO 13485:2016 clause 4.2.5 and FDA 21 CFR 820.180. Implantable-adjacent device programs (CGM patches, defibrillator accessories) get 15 years. Records include serial-level cell traceability, lot test data, and the full cell DMR. Audit retrievals typically resolve within 5 business days.
Will you sign a quality agreement?
Yes. We sign mutual quality agreements before any program kickoff, covering: change-notification (we notify of any material, process or facility change ≥ 30 days before implementation), CAPA cooperation, complaint handling SLAs, audit rights and record-retention period. NDAs in 1 business day; QAs typically in 7 to 10 business days after legal review.
Engineering deep-dives.
China's Medical Device Battery Landscape
How NMPA-driven localisation is reshaping wearable-medical supply.
Read the analysis →IEC 62133-2 Complete Walkthrough
Every mandatory and conditional test, with cost and timeline data.
Read more →Polymer Lithium Battery
The pouch-cell platform behind every medical wearable we ship.
Explore the pillar →Working on a medical program?
We sign quality agreements and support your DHF from feasibility through PMS. NDAs in 1 business day, QA in 7 to 10.
Start a Medical Project