Monitor Line for a European Distributor
Private-label 12" monitors with custom UI, CE technical file transferred in 9 months.
Precision Devices, Manufactured to Clinical Standard
OEM and ODM contract manufacturing of patient monitoring, infusion and hospital care devices. ISO 13485 quality system, Class 100,000 cleanrooms, CE marking and FDA 510(k) documentation support.
- ISO 13485:2016
- CE MDR
- FDA Registered
- ISO Class 8 Cleanroom
18years manufacturing for medical brands
4,200 m²ISO Class 8 cleanroom area
60+countries with registered devices
98.6%first-pass yield across 2025 lots
Six Device Families Under One Roof
Electronics, plastics and final assembly integrated on one campus, so design changes move in days rather than shipping cycles.
Patient Monitors
3 to 15 inch multi-parameter monitors, ECG, SpO2, NIBP modules
Class II
Infusion Systems
Volumetric pumps and syringe drivers with drug library software
Class II
Hospital Beds
Electric ICU and ward beds, 3 to 5 function, weighing option
Class I
Surgical Instruments
German-grade stainless sets, laparoscopic and general surgery
Class I / II
Sterile Disposables
Infusion sets, catheters and kits, EO sterilized in-house
Class II
Homecare Devices
Oxygen concentrators, nebulizers and BP monitors for retail brands
Class IIYour Brand, Our Quality System
Four engagement models, from label-only OEM to full ODM development with your name in the technical file.
A
Private Label OEM
Existing registered devices carrying your brand, packaging and IFU. Fastest route to market, MOQ from 200 units.
B
Custom ODM Development
Industrial design, firmware and clinical documentation developed to your specification under design control per ISO 13485 §7.3.
C
Contract Manufacturing
Your design transferred to our lines: SMT, injection molding, cleanroom assembly and EO sterilization with full DHR per lot.
D
Regulatory Support
CE technical files, FDA 510(k) submission data, CFDA export certificates and country registration dossiers prepared by our RA team.
Built Inside the Quality System, Not Around It
Every lot is traceable from incoming material to shipped carton. Device history records are digital, audit-ready and shared with your RA team on request.
- ISO 13485:2016 certified by TÜV SÜD, audited annually
- 4,200 m² ISO Class 8 cleanrooms with monitored particle counts
- In-house EO sterilization validated to ISO 11135
- IEC 60601 electrical safety lab with climate chambers
- Incoming, in-process and final inspection to AQL 1.0
Who We Manufacture For
Hospital & ICU Distributors
Monitors, beds and infusion systems for tenders across 60+ registered markets, with tender documentation support.
Homecare & Retail Brands
Consumer medical devices developed for pharmacy chains and e-commerce brands, retail packaging included.
Clinics & Laboratories
Diagnostic support devices and consumable kits for outpatient and lab networks, small-lot flexible supply.
Device Companies Outsourcing Production
US and EU device firms moving assembly to a 13485 site while keeping design authority in-house.
From RFQ to Registered Device
- 01
Requirement review
Spec, target market and classification confirmed within 48 h.
- 02
Samples & DVT
Engineering samples with test reports in 3–6 weeks.
- 03
Documentation
Technical file, IFU and labeling to your market's regulation.
- 04
Pilot & validation
Process validation lots with IQ/OQ/PQ records.
- 05
Mass production
Lot release with DHR, pre-shipment inspection welcomed.
Recent OEM Programs
Infusion Sets for LATAM Tenders
ANVISA-registered sets with in-house EO sterilization and lot-level dossier per shipment.
ICU Beds for a Gulf Hospital Group
5-function beds delivered in 3 phases with site training and 10-year spare parts contract.
Guides for Device Buyers
OEM vs ODM in Medical Devices: Who Owns the Technical File
The ownership question that decides whether you can ever switch manufacturers.
ReadHow to Audit a Chinese Medical Device Factory in One Day
The records to pull, the rooms to walk, and the questions that expose a paper QMS.
ReadCE MDR Timeline for Private-Label Devices in 2026
Realistic notified-body queues and what documentation you can prepare in parallel.
ReadFrequently Asked Questions
What certifications does VITALCRAFT hold?
Our quality system is certified to ISO 13485:2016 by TÜV SÜD. Devices carry CE marking under MDR 2017/745 where applicable, and our facility is registered with the US FDA. We provide test reports to IEC 60601-1 and biocompatibility data to ISO 10993 for relevant products.
Can you manufacture under our brand name?
Yes. Private-label OEM is our largest business line. Your brand appears on the device, packaging, IFU and, where regulations allow, on the registration itself. We sign non-compete agreements covering your registered markets.
What are typical MOQs and lead times?
Catalog devices start at 200 units for electronics and 50 for hospital beds, with 30 to 45 day lead times. Custom ODM programs depend on tooling and validation scope; engineering samples typically ship in 3 to 6 weeks after specification freeze.
Do you support FDA 510(k) submissions?
We prepare the manufacturing sections: device master record, process validation, sterilization validation and biocompatibility test data, and coordinate with your US regulatory consultant who acts as submitter. Several current customers hold 510(k)s built on our data packages.
Can we audit the factory before ordering?
We encourage it. On-site audits take one to two days with full access to the QMS, cleanrooms and testing labs. If travel is difficult we run live video audits with document sharing, and we accept third-party audits by SGS, TÜV or your own consultants.
Send Your Specification
Attach a spec sheet, tender document or reference product. A project engineer replies within one working day with feasibility, price band and timeline.
- 2416915170@qq.com
- +86 159 6208 2932
- MedTech Park, Suzhou Industrial Park, Jiangsu, China