ISO 13485 Certified · Hyderabad, India · Est. 2022

Precision
Manufacturing

End-to-end OEM solutions across electro-mechanical devices, wearables, custom electronics and cleanroom assembly — plus our own certified device portfolio led by the SG Balloon Sinuplasty System.

0
sq.ft Facility
2
Production Units
0
Units / Month
8
Capabilities
SG Balloon Sinuplasty System
📷 Integrated Camera
💧 Smart Irrigation
🎯 Steerable Tip
🏅 Patent Pending
ISO 13485
Quality Management
IEC 60601
Medical Electrical Safety
🔬
ISO Class 7 & 8
Cleanroom Certified
🌐
FDA / CE Ready
Global Market Access
🇮🇳
CDSCO
MD Rules 2017
About SGPMS

Vertically Integrated Medical Device Manufacturer

🏭
OEM Manufacturing Partner
Design to certified device, entirely in-house. Trusted precision manufacturer for global medical device companies.
🩺
Own Device Portfolio
Launching proprietary devices including the SG Balloon Sinuplasty System (Patent Pending) — camera, irrigation and steerable tip integrated.
⚙️
Zero External Dependency
Design, rapid prototyping, cleanroom assembly, in-house CNC tooling, custom automation and regulatory support — all in-house.
Our Facilities

🏭 Unit 1 — Primary Production

15,000 sq.ft · 4 Floors · 4,500 sq.ft ISO Class 8 · 1,000 sq.ft ISO Class 7
📍 ALEAP Industrial Estate, Kukatpally

🏗️ Unit 2 — Expansion

12,000 sq.ft · 2 Floors · 3,000 sq.ft ISO Class 8 Cleanroom
📍 Jeedimetla Industrial Area

0
sq.ft Total
5.5K
Clean sq.ft
8
Capabilities
3
Reg. Markets
SG Balloon Sinuplasty System
🏅 Patent Pending — Novel Integrated Design

SG Balloon Sinuplasty System
Next-Generation ENT Innovation

A first-of-its-kind minimally invasive balloon sinus dilation system that integrates camera visualisation, smart irrigation and a steerable tip — all in one ergonomic device. Engineered for precision, built to global medical standards.

📷
Integrated Camera Visualisation
Built-in optics for real-time intra-nasal visualisation — no separate scope required, reducing setup complexity.
💧
Smart Irrigation System
Controlled saline irrigation for continuous field clarity throughout the procedure.
🎯
Steerable Tip Mechanism
Active tip deflection for precise catheter navigation through complex sinus anatomy.
🎈
Precision Balloon Dilation
Controlled inflation for atraumatic, reproducible sinus ostia dilation with verified pressure feedback.
Product Portfolio

Devices We Build & Launch

From infusion systems to wearable biosensors — precision-built, certified and delivered entirely in-house.

Balloon Sinus Device
SG Balloon Sinuplasty System
Integrated camera, irrigation & steerable tip balloon dilation system. Next-generation minimally invasive ENT device. Patent Pending.
Patent PendingCameraSteerable
Syringe Pump
Dual-Channel Syringe Pump
Precision infusion system with touchscreen HMI, dual stepper-motor drive and IEC 60601 compliance. IoT-enabled medication management.
Electro-MechanicalIEC 60601IoT
ECG Wearable
2-Channel ECG Wearable
Ambulatory cardiac monitor with dry electrodes, BLE data streaming and real-time SpO₂ tracking. Patient-worn biosensor with cloud connectivity.
WearableBLE 5.0ECG/SpO₂
Custom PCB
Custom Medical-Grade PCBs
Multi-layer biomedical PCBs with WiFi, BLE, ECG AFE and power management. SMT to IPC-A-610 Class II/III with AOI inspection.
SMT/THTIPC-A-610BLE/WiFi
Full-Spectrum Manufacturing

Eight Integrated Capabilities

Every step from concept to certified device — entirely in-house, zero external dependencies.

01
⚙️
Electro-Mechanical Devices
Touchscreen HMI systems, syringe pumps, infusion systems, precision drive mechanisms and IoT-enabled dispensers.
Servo PLCIEC 60601DWIN HMI
02
🩺
Wearable Medical Devices
CGM sensors, 2-channel ECG, women's health monitors and multi-parameter biosensors with wireless connectivity.
BLE/IoTECG/CGMSpO₂
03
💻
Custom Electronics & PCBs
Multi-layer PCB design, biomedical AFE circuits, SMT/THT assembly to IPC-A-610 Class II/III with AOI inspection.
SMT/THTIPC-A-610WiFi/BLE
04
🖨️
Rapid Prototyping
Concept to prototype in 24–48 hours: FDM (0.1–0.3mm), SLA (25μm) and vacuum casting with silicone & PU resin.
FDMSLAVacuum Cast
05
🔩
Injection Molding
40T & 80T vertical presses with in-house CNC tooling. Medical-grade PEBAX, Nylon, ABS, PC and USP Class VI.
40T/80TCNC ToolingUSP VI
06
🧪
Cleanroom Assembly
ISO Class 7 (<10,000 p/m³) and Class 8 cleanrooms for critical device and PCB assembly with full lot traceability.
ISO 7/8HEPADHR/Lot
07
🤖
Custom Automation
Bespoke catheter processing machines, reflow systems, FEP expansion, skiving and heat bonding with ±0.5°C control.
CatheterPLC/ServoIQ/OQ/PQ
08
📋
Regulatory Affairs
Full DHF and technical documentation for FDA 510(k), CE MDR 2017/745 and CDSCO. Risk management, V&V and UDI.
FDA 510(k)CE MDRCDSCO
Custom Automation Solutions

Medical Device Manufacturing Automation

We design, build and validate custom automation machines entirely in-house — from catheter processing systems to multi-zone thermal bonding equipment. Every machine delivered with IQ/OQ/PQ documentation.

🔧
Catheter Processing Equipment
Lamination & reflow systems, FEP heat-shrink expansion, precision tip skiving machines.
🌡️
Thermal Processing Systems
Heat bonding & tip forming with ±0.5°C control, multi-zone simultaneous processing.
🖥️
PLC & Servo Motion Control
In-house design and programming of PLC-controlled systems with touchscreen HMI panels.
📋
IQ / OQ / PQ Validation Ready
FAT & SAT support. ISO 13485-compliant process documentation delivered with every machine.
Automation Machine
Vertical Machine
Catheter Laminating Machine
End-to-End Delivery

Design to Certified Device

💡
Design
🖨️
Prototype
🧪
Testing
🏭
Manufacture
📋
Regulatory
Certified
🚀
Mass Prod.
Global Market Access

Regulatory Expertise

Complete documentation packages for FDA, CE MDR and CDSCO — prepared in-house, end to end.

🇺🇸
United States (FDA)
  • 510(k) Premarket Notification
  • Design History File (DHF)
  • Device Master Record (DMR)
  • Risk Management · ISO 14971
  • 21 CFR Part 820 / QSR
🇪🇺
European Union (CE MDR)
  • Technical Documentation (TD)
  • Declaration of Conformity
  • Clinical Evaluation Report
  • Post-Market Surveillance
  • MDR 2017/745 · IVDR
🇮🇳
India (CDSCO)
  • Class A/B/C/D Registration
  • Import / Manufacture License
  • MD Rules 2017 Compliance
  • Essential Principles Checklist
  • Authorised Agent Support
📁
QMS & Documentation
  • DHF / DMR / Change Control
  • ISO 14971 FMEA / Risk
  • IQ / OQ / PQ Validation
  • SOPs · NCR · CAPA · Audits
  • UDI · EUDAMED · GUDID
Get In Touch

Ready to Build Together?

Whether you need a precision OEM partner, a custom device built to spec, or want to enquire about our Balloon Sinuplasty System — we're ready to collaborate.

Locations
📍 Unit 1 — ALEAP Industrial Estate, Kukatpally
📍 Unit 2 — Jeedimetla Industrial Area