Medical devices & lab equipment
Precision devices, built for global regulatory clearance.
Vitalis Medical Systems designs and manufactures patient monitoring, infusion and laboratory equipment for OEM partners and distributors in 80+ countries — from ISO Class 8 cleanrooms in Suzhou.
ISO 13485:2016
CE MDR 2017/745
FDA-registered
IEC 60601-1
Device lines
Six product families, one quality system
Every line ships from the same ISO 13485 quality system — shared components, shared documentation, one audit for your whole catalog.
Patient monitoring
Multi-parameter monitors, telemetry units and central stations covering ward-to-ICU acuity levels.
In-vitro diagnostics
Benchtop analyzers, immunoassay readers and rapid-test instrumentation for clinical laboratories.
Laboratory equipment
Centrifuges, CO₂ incubators, shakers and sample-prep systems built for around-the-clock duty cycles.
Infusion & fluid management
Volumetric and syringe pumps with dose-error reduction software and full accessory ecosystems.
Sterile single-use devices
Tubing sets, pressure transducers and custom procedure kits, EO-sterilized and lot-traceable.
Cold-chain & transport
Validated 2–8 °C vaccine carriers, sample shippers and temperature loggers with lane reports.
Featured platforms
Ready-to-brand devices
Proven platforms with CE technical files — rebadge, relabel, ship.
Model VM-9000
MOQ 50 units
Lead 30 days
Multi-parameter patient monitor
12.1″ touchscreen, ECG/SpO₂/NIBP/Temp/Resp, HL7 export and a hot-swappable 8-hour battery.
Model LC-450
MOQ 100 units
Lead 25 days
Benchtop laboratory centrifuge
4,500 rpm swing-out rotor, 24-tube capacity, imbalance detection and brushless drive rated for 10,000 hours.
Model IP-720
MOQ 50 units
Lead 35 days
Volumetric infusion pump
0.1–1,200 mL/h range, ±5% accuracy, dose-error reduction library and free-flow protection to IEC 60601-2-24.
Manufacturing
Controlled environments, measured output
2,600 m²
ISO Class 8 cleanroom production, monitored to ISO 14644-1
11
Assembly and calibration lines with 100% end-of-line testing
1.2M
Devices and sterile kits shipped annually to 80+ countries
99.6%
Lot acceptance rate across incoming, in-process and final QC
Quality & regulatory
Quality is designed in — then verified at every gate
Our quality management system covers the full device lifecycle, so your technical documentation is audit-ready the day the first container leaves the dock.
- Design history files and risk management to ISO 14971
- IQC, IPQC and OQC inspection with AQL sampling plans
- In-house IEC 60601-1 electrical safety and EMC pre-test lab
- Serial-number and UDI traceability on every unit shipped
- CAPA and post-market surveillance with annual trend reviews
Certifications & registrations
ISO 13485:2016
CE MDR 2017/745
FDA establishment reg.
ISO 9001:2015
ISO 14971
IEC 60601-1
Technical files, declarations of conformity, test reports and free-sale certificates are available to qualified partners under NDA — typically within two business days.
OEM & contract manufacturing
From requirement to release in six controlled phases
Every phase closes with a documented design review — you sign off before we spend your tooling budget.
01 +
Requirements & feasibility
NDA, target specification, regulatory pathway and unit-cost model returned within ten working days.
02 +
Design & documentation
Industrial design, electronics and firmware developed against a complete design history file.
03 +
Verification builds
EVT and DVT prototypes tested in our IEC 60601-1 safety lab before any tooling is cut.
04 +
Process validation
Pilot lots under IQ/OQ/PQ protocols with first-article inspection and AQL sampling plans.
05 +
Regulatory support
CE technical files, FDA 510(k) data packages and country registrations prepared with our RA team.
06 +
Production & lifecycle
Serialized mass production, UDI labeling, CAPA follow-up and ten-year spare-parts availability.
Packaging & logistics
Sterile to the dock, cold to the door
Packaging is part of the device, not an afterthought. Barrier systems, labeling and lane-qualified shipping are validated together, then documented in your lot file.
- Sterile barrier systems validated to ISO 11607
- EO sterilization with residual testing per ISO 10993-7
- 120-hour validated 2–8 °C shippers with calibrated loggers
- FOB, CIF or DDP incoterms by sea and air, weekly consolidations
Sterile barrier packaging
Tyvek pouches, blister trays and header bags sealed in-line in the cleanroom, with seal-strength and dye-penetration testing on every lot and UDI-compliant labeling.
Cold-chain shipping
Qualified shippers for reagents and temperature-sensitive kits, calibrated data loggers in every carton, and lane qualification reports for your top routes.
Partners
What distributors tell their auditors
“Vitalis took our monitor line from tech pack to CE-marked shipment in nine months. Three notified-body audits later, still not a single major finding on their file.”
Karim Al Rawi — Managing Director, Al Rawi Medical Trading, Dubai
Distributor since 2016 · 4 GCC tenders won
“The documentation arrives before the freight does. When you handle tenders in four countries, a supplier whose paperwork is always complete is the whole game.”
Sofia Lindgren — Procurement Lead, NordicCare Supplies, Copenhagen
Distributor since 2019 · 300+ lab installs
Request for quotation
Send the spec. Get a compliant quote in 48 hours.
Attach your tender specification or target datasheet — our engineers reply with pricing, MOQ, lead time and the regulatory documents your market requires.
Average first response: 6 business hours · English, 中文, Español