☰

Integrated Engineering + Medical Device OEM Platform

Build in India  |  Manufacture for the World

Est. 1988 11,500 sq.m. Facility ISO 13485 Certified 10+ Export Countries 35+ Years Experience

Company Background

Precision engineering rooted in Gujarat — serving global medical, aerospace, and industrial markets since 1988.

1988
Year Established
11,500
Sq. Meters Facility Area
10+
Countries Exported To
35+
Years of Precision Engineering
5+
Core Sectors Served
🏭 ISO 13485 Quality System ⚙️ Precision Engineering Since 1988 🔌 Electronics + Mechanical Integration 🌍 Global Export Experience

Infrastructure Overview

World-class machining, fabrication, and medical electronics infrastructure under one roof.

⚙️ Precision Machining

  • CNC Machining Centers
  • VMC Machines
  • Surface Grinding Units
  • Die & Mould Fabrication
  • Special Purpose Machine Development
  • Precision Tool Room
  • Welded Structures & Fabrication

🔌 Electronics Manufacturing (SMT + PCB)

  • Semi-auto Stencil Printing
  • Mid-speed Pick & Place
  • Reflow Soldering
  • AOI Inspection
  • ESD Workstations
  • Functional Test Benches
  • PCB Rework Stations
Annual PCB Assembly: 2–3 Million Boards

🏥 Electro-Mechanical Device Assembly

  • Controlled Assembly Stations
  • Torque-controlled Precision Tools
  • Ultrasonic Welding
  • Laser Marking (UDI-ready)
  • Leak Testing Rigs
  • Flow Calibration Systems
  • Functional Validation Benches

✅ Quality & Compliance Platform

  • ISO 13485 QMS
  • Risk Management (ISO 14971)
  • Device Traceability System
  • Batch-level Serialization
  • CDSCO Registration
  • CE Documentation Framework Ready
  • EMC & Safety via Accredited Labs

Combined Capacity — Engineering + Medical

Precision machining and medical electronics capacity designed for high-volume, globally compliant production.

Capability Capacity / Scale
CNC Machining 24/7 batch production
Die & Mould Manufacturing High precision industrial scale
SPM Development Custom automation systems
Surface Grinding Aerospace tolerance grade
PCB Assembly (SMT Line) 2–3 Million boards per annum
Medical Device Assembly Scalable OEM volumes
Quality & Compliance ISO 13485 | ISO 14971 | CDSCO | CE Ready

Service Model

Flexible engagement models designed to match every stage of your device lifecycle.

🏗️ Manufacturing Services

  • Full Contract Manufacturing (CM)
  • OEM White Label Manufacturing
  • Sub-assembly Manufacturing
  • End-to-End Product Assembly

🔧 Engineering Services

  • Design Transfer & Scale Manufacturing
  • Electronics + Mechanical Integration
  • Industrialization Support

Verticals We Serve

From diagnostics to wearables — our platform supports a broad range of medical device categories.

🫁
Respiratory Devices (CPAP)
🔬
Diagnostic Devices
📊
Patient Monitoring
🏥
Hospital Equipment
⌚
Wearable Health Devices
🧪
Portable POC Systems
💡
Embedded Medical Electronics

Value Proposition for OEM Clients

Why global medical device companies choose 369 Innovations as their manufacturing partner.

35+ Years Precision Engineering Experience

In-house Tooling & Die Capability

In-house SPM & Automation Development

Electronics + Mechanical Under One Roof

Lower CapEx & Tooling Dependency

Indian Manufacturing Cost Advantage

Export Documentation Experience

Modern Electronics Manufacturing

Medical Quality Systems (ISO 13485)

Scalable Contract Manufacturing

Scalability Roadmap

A phased expansion strategy built for global OEM scale.

01

Phase 1 — Current Platform

  • Lean electronics manufacturing
  • Electro-mechanical OEM assembly
  • ISO 13485 QMS operational
  • CDSCO registration active
02

Phase 2 — Expandable

  • Automated SMT lines
  • Cleanroom expansion
  • FDA 510(k) compliance pathway
  • Large volume export production
03

Phase 3 — Global OEM Platform

  • High-volume global OEM exports
  • Multi-region regulatory compliance
  • Full-stack device manufacturing

Target Client Profile

🚀
Global MedTech Startups
🇪🇺
European CE Device Brands
🇺🇸
US Mid-size Medical Device Firms
🏥
Indian Hospital Equipment Manufacturers
🔬
Diagnostic Innovators
⌚
Wearable Health-Tech Brands

Strategic Differentiator

What We Combine

Precision Mechanical + Tooling + Automation + Electronics — all in-house.

What This Enables

  • Faster product transfer
  • Lower tooling cost
  • Better sensor & housing integration
  • Improved cost control

Positioning Statement

369 Innovations is positioned as an integrated precision engineering and medical electronics OEM platform — capable of delivering globally compliant devices with scalable production capacity and a significant cost advantage emerging from India.

Ready to Scale Your Medical Device Manufacturing?

Let's discuss how our integrated platform can reduce your manufacturing risk, cut costs, and accelerate time-to-market for global markets.

Schedule a Strategic Discussion Partner With 369 Innovations