Medical · ISO 13485 · 21 CFR Part 820
MEDICAL DEVICE CABLES
BUILT IN A CLEANROOM CARVE-OUT.
Patient-monitor cables, infusion-pump harnesses, diagnostic-imaging signal lines. ISO 13485 documented since 2017, FDA 21 CFR Part 820 process-aligned, USP Class VI biocompatible TPU and PVC-free jackets stocked locally.
ISO13485
Certified Since 2017
21CFR 820
FDA Aligned
USP-VI
Biocompatible Stock
DMR/DHR
Per Device Family
ISO 13485
Since 2017 · Annual Recert
21 CFR 820
Process-Aligned
Cleanroom
Carve-Out · Class 100K Eq.
USP-VI
TPU Materials Library
What We Build for Medical OEMs
FROM PATIENT MONITOR
TO MRI ROOM.
XUDONG Cavite serves Class II and Class III medical device OEMs across the United States, Germany, Japan and Korea. Our medical cable portfolio includes patient-monitor cables (ECG, SpO2, NIBP, IBP, temperature), infusion pump harnesses, diagnostic-imaging signal cables (ultrasound transducer, endoscope camera), and equipment-side cables for surgical robots and dental imaging chairs.
All medical builds run inside a cleanroom carve-out with garment, glove and ESD-strap protocols. We maintain a Device Master Record (DMR) and Device History Record (DHR) per device family — engineering change orders flow through a documented design-control loop tied to ISO 13485 §7.3. Material library is biased toward USP Class VI TPU and PVC-free jackets, which we stock locally for sub-7-day repeat lead time.
Programs route through overmolded harness cells when patient-contacting strain reliefs are required, our custom wire harness workflow for diagnostic-imaging cables, and electromechanical assembly for cabinet-level diagnostic imaging modules.
Japan-Domiciled Client Support
For Japanese medical device OEMs, XUDONG operates a Tokyo-based subsidiary (Xudong Japan Co., Ltd., Fuchu-Shi) that supports Japanese-language pre-sales, drawing review, quality-document exchange, and on-site visit coordination. Wire harness production stays in Cavite, while program management can run end-to-end in Japanese — useful for ISO 13485 documentation, FDA submission support, PMDA stakeholder coordination, and IATF 16949 audits where Japanese-side communication needs to stay precise.
Medical Capability Matrix
SIX MEDICAL
SPECIALIZATIONS.
Built to ISO 13485 since 2017. Cleanroom carve-out audited monthly.
Patient-Monitor Cables
ECG, SpO2, NIBP, IBP, temperature lines. DIN 42802 / Redel / Lemo / proprietary connectors. USP Class VI TPU jacket default.
Infusion Pump Harness
Pump motor lines, occlusion sensor leads, AC/DC power-supply harnesses. Strain relief overmolded with USP-VI TPE.
Diagnostic Imaging Cables
Ultrasound transducer cables (multi-element coax), endoscope camera cables, dental panoramic head cables.
Cleanroom Build Discipline
Carve-out with Class 100K equivalent overhead filtration. Garment, glove, ESD-strap protocol audited monthly.
DMR + DHR per Device Family
Device Master Record + Device History Record maintained on segregated server. ISO 13485 §7.3 design-control loop.
Biocompatible Materials
USP Class VI TPU, PVC-free jackets, latex-free overmold. ISO 10993-5/-10 cytotoxicity / sensitization data on file.
Buyer Pain Points
FOUR THINGS THAT
SLOW MEDICAL PROGRAMS.
Challenge #1
Biocompatibility evidence gaps after a material change
Your contract manufacturer swaps a PVC compound source mid-program; the existing ISO 10993-5 cytotoxicity report is now invalid against the new lot. Regulatory submission slips three months while you re-run animal testing.
How XUDONG addresses it
We lock biocompatible materials at PPAP-equivalent gate — every USP-VI TPU lot is sourced from the same compound supplier under a controlled material specification. ISO 10993-5/-10 / -11 reports stay valid because the formulation does not drift.
Challenge #2
DMR/DHR drift between supplier and device file
Your device master record references a 2021 cable revision; your supplier produces 2024 revision because they changed insulation supplier. FDA inspection finds the gap and your QMS opens a CAPA.
How XUDONG addresses it
Engineering change orders flow through a single ECO board. Cable revision is locked to BOM revision; revision label is printed on every harness. Supplier-side material changes trigger automatic DMR review before production.
Challenge #3
Cleanroom protocol violations from cross-trained operators
An operator who builds automotive harnesses on Tuesday and medical on Wednesday brings a contamination risk — fiber, oil, skin cells — into a Class 100K carve-out unless protocol is enforced.
How XUDONG addresses it
Medical operators are dedicated, not cross-trained from automotive lines. Garment, glove and ESD-strap protocol audited daily by quality cadre. Cleanroom carve-out has air-shower entry and dedicated tooling kit.
Challenge #4
Sterilization compatibility unknowns (EtO / gamma / autoclave)
Your device-level sterilization is gamma at 25 kGy. The cable jacket your supplier picked is rated to gamma but only at 15 kGy; resistance drift after sterilization fails functional test.
How XUDONG addresses it
Material library tagged by sterilization compatibility (EtO / gamma 25–50 kGy / steam autoclave). We pre-screen jacket and overmold compounds against your sterilization spec at DFM stage and flag any mismatches before quotation.
Design-Control Timeline
DESIGN INPUT
TO DHR RELEASE.
Design Input + DFM
Customer hands over design input, DMR scope, biocompatibility / sterilization requirements.
Material Pre-screen
USP-VI TPU options short-listed. ISO 10993 / sterilization matrix checked before quote.
Sample + Verification
First-article sample 5–7 days. Customer-side design verification per IEC 60601-1 if applicable.
DMR + DHR Build
Device Master Record assembled with material certs, work instructions, control plan, test protocols.
Cleanroom Production
Carve-out builds with garment, glove, ESD discipline. 100% Cirris continuity + dielectric.
DHR Release
Per-lot Device History Record signed off. Serialized to operator, terminal lot, sterilization batch (if applicable).
Anonymized Case Study
US TIER-1 PATIENT MONITOR OEM
(PUBLICLY HELD).
Customer: NYSE-listed US patient-monitoring OEM (Class II 510(k)-cleared device family). They needed to dual-source 8 SKUs of patient cable — ECG 3-lead, ECG 5-lead, SpO2 reusable, NIBP, IBP, temperature, defibrillator paddles, and pacing cable — out of an Asian site after their incumbent Mexican supplier missed two consecutive on-time targets.
We took over Q2 2023. Material library locked at USP-VI TPU. Cleanroom carve-out validated via on-site audit by customer quality. First production lot shipped week 9. Through 2024, we delivered 48,000 cables across the 8 SKUs with zero device-level field complaint and 99.6% on-time delivery to customer line.
48K
Cables Shipped 2024
0
Field Complaints
99.6%
OTD to Line
18%
Cost Reduction vs MX
Solution Stack Applied
Cleanroom carve-out validated
Customer quality on-site audit Q2 2023; closure rate 100%.
USP-VI TPU material lock
Single compound source per SKU; ISO 10993-5/-10/-11 reports on file.
DMR + DHR segregated
Device Master Record on dedicated server; revision-locked to customer ECO.
100% functional + dielectric test
Cirris continuity + insulation resistance + dielectric on every cable.
Sterilization compatibility verified
EtO at 50 kGy gamma equivalent verified before pilot lot.
Lot-level DHR sign-off
Per-lot operator + terminal lot + jacket lot recorded; signed by quality cadre.
Founder Note · Mr. Fei Bo Hu
“Medical cable work taught us that documentation is half the product. A patient-monitor cable is mechanically simpler than a 600 V EV harness, but the DMR + DHR + sterilization-compatibility paper trail takes more engineering hours than the assembly itself. We built our medical line around that reality — documentation engineers sit on the line, not in head office.”
— Mr. Fei Bo Hu, President · Xudong Group
Medical Buyer FAQ
SIX QUESTIONS MEDICAL
OEMS ALWAYS ASK.
Q.01Are you ISO 13485 certified by an FDA-recognized notified body?
+
Are you ISO 13485 certified by an FDA-recognized notified body?
Q.02Do you maintain DMR (Device Master Record) and DHR (Device History Record) per device family?
+
Do you maintain DMR (Device Master Record) and DHR (Device History Record) per device family?
Q.03What biocompatible materials do you stock and what testing data is on file?
+
What biocompatible materials do you stock and what testing data is on file?
Q.04Can your cleanroom build cables that go inside a sterile barrier?
+
Can your cleanroom build cables that go inside a sterile barrier?
Q.05How do you handle FDA 21 CFR Part 820 process validation?
+
How do you handle FDA 21 CFR Part 820 process validation?
Q.06What is the lead time for a new medical cable program from RFQ to first production lot?
+
What is the lead time for a new medical cable program from RFQ to first production lot?
Related Services
HARNESS TYPES
FOR MEDICAL.
Overmolded Harness
Patient-cable strain reliefs in USP-VI TPE / TPU. Single-shot to two-shot biocompatible overmold up to 65 Shore-A.
Read moreCustom Wire Harness
Diagnostic-imaging signal cables, multi-element coax for ultrasound, endoscope camera leads.
Read moreElectromechanical Box Build
Cabinet-level assembly for diagnostic imaging modules, infusion pump enclosures, dental imaging chairs.
Read moreMedical / ISO 13485
Medical Device Harnesses · Cleanroom Carve-Out.
ISO 13485 cleanroom build with full DMR / DHR per program. BMS, patient-monitor, infusion-pump and ECG signal harnesses.
BMS multicolor twisted pair
Battery monitoring interconnect
Shielded multicolor PH signal
EMI-shielded, multi-conductor
Real Project Snapshot · US · electrical-supply · 2024
A Build We Already Shipped In This Lane.
Scenario
A US electrical supply distributor required custom wire harnesses with specific Molex connectors, but a production batch had a dyeing/color deviation on the connector housings.
Challenge
Approximately 200 pieces of the wire harness assembly had connector coloring that did not match the strict aesthetic and technical requirements, risking rejection and project delay.
Outcome
Successfully reworked and delivered the batch without losing the client's trust; the client continued to place repeat orders in the following months without quality complaints.
Anonymized customer detail. Concrete numbers preserved verbatim.
Next Step
Cleanroom Builds. DMR/DHR. Day One.
Send your device classification, biocompatibility requirements and connector list. Our medical engineering desk replies within 12 hours with a sample plan. Quote returned within 12 hours. NDA on file. No obligation.