How we do it .
Manufacturing facility
Precision Manufacturing for Critical Care Devices
At Lub Dub Medical Technologies Pvt Ltd, we engineer and manufacture high-performance medical device accessories trusted in hospitals, clinics, and emergency care settings worldwide. Our core product lines include ECG Cables, SpO₂ Sensors, NIBP Cuffs, Temperature
Probes, and Ventilator Patient Circuits—each built to deliver accuracy, durability, and patient safety.
Backed by ISO 13485 certification, CDSCO registration, and full compliance with IEC 60601 standards, our end-to-end manufacturing process ensures every device meets the highest global regulatory and clinical requirements.
Our Products
We specialize in essential patient connectivity solutions used across monitoring and life support systems:
- ECG Cables & Lead Wires – Multi-lead configurations for adult, pediatric, and neonatal applications.
- SpO₂ Sensors – Reusable and disposable sensors with consistent signal performance.
- NIBP Cuffs – Durable, comfortable cuffs in all sizes—from neonatal to adult.
- Temperature Probes – Fast-response probes for continuous core and surface temperature
monitoring. - Ventilator Patient Circuits – Single-use breathing circuits with optional heated wire
technology.
All products are designed for compatibility with leading patient monitors and ventilators.
Advanced Manufacturing Process
From concept to delivery, every device undergoes a tightly controlled production journey in our modern, cleanroom-equipped facility.
Precision Engineering & Design
- Product development guided by usability engineering and risk analysis (ISO 14971).
- Rapid prototyping and simulation testing ensure optimal performance before scale-up.
High-Quality Material Sourcing
- Medical-grade materials only: silicone, PVC, copper conductors, TPU, TPE,TPR,TPV, USP Class VI plastics.
- All suppliers audited and approved under our Quality Management System.
Automated & Manual Assembly
- Hybrid production lines combine automation (for consistency) and skilled technicians (for precision).
- Cleanroom assembly (Class 10,000) for SpO₂ sensors and ventilator circuits.( Proposed)
- Real-time barcode tracking from component to final packaging.
Final Assembly & Packaging
- Devices assembled, inspected, and packaged in contamination-controlled environments.
- Sterile products terminally sterilized via Ethylene Oxide (EO) or Gamma irradiation.
- Tamper-evident, labeled packaging with UDI compliance.
Quality Testing
Quality isn’t just checked—it’s built into every step.
| Product | Key Tests Performed |
|---|---|
| ECG Cables | Continuity, impedance, noise immunity, flex durability |
| SpO₂ Sensors | Optical output, pulse detection, signal stability (70–100% SpO₂) |
| NIBP Cuffs | Air leak test, pressure accuracy, inflation/deflation timing |
| Temperature Probes | Calibration against NIST-traceable standards, response time |
| Ventilator Circuits | Leak test, airflow resistance, dead space, condensation management |
Additional Validation
- Biocompatibility (ISO 10993): Non-cytotoxic, non-irritating, non-sensitizing
- Environmental Stress Testing: Thermal cycling, drop tests, shelf-life validation
- 100% visual inspection and functional verification before release
All test data is documented in Device Master File (DMF) for full traceability.
Smart Storage & Inventory Control
To protect product integrity, we maintain climate-controlled warehousing:
- Temperature: 15–25°C
- Humidity: 30–60% RH
- Light-sensitive items stored in UV-protected containers
Our ERP system enables:
- Lot and batch-level traceability
- FEFO (First-Expiry, First-Out) inventory rotation
- Real-time stock visibility for OEM and distribution partners
Global Logistics & Distribution
We ensure your orders arrive safely, on time, anywhere in the world.
Shipping Capabilities
- Worldwide air, sea, and land freight options
- Cold-chain logistics available for temperature-sensitive shipments
- Partnered with certified medical device distributors and 3PL providers
Compliance-Ready Documentation
- Certificates of Analysis (CoA)
- Certificates of Conformance (CoC)
- Free Sale Certificates
- UDI-compliant labeling
Custom kitting, private labeling, and multi-language packaging available upon request.
Certifications & Compliance
We adhere to the highest international standards:
- ISO 13485:2016 Certified
- CDSCO Registered Facility
- RoHS & REACH Compliant
- ISO 10993 Biocompatibility Tested
Regular internal audits and third-party inspections ensure ongoing compliance.
Partner With Us
Whether you’re a healthcare provider, OEM, or distributor, Lub Dub Medical Technology offers:
- Custom design & co-development services
- Private labeling and contract manufacturing
- Scalable production volumes
- Reliable supply chain continuity
Let’s build safer, smarter patient care solutions—together.
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