India Manufacturing Access — Without the Identification and Qualification Risk.

The right partner. Vetted. Qualified. Continuously governed. We connect you to India's best-fit medical device manufacturing partners — and stay engaged to ensure they perform.

The Problem We Solve

India's medical device manufacturing ecosystem offers significant cost and scale advantages. But selecting the wrong partner — inadequate quality systems, undisclosed process gaps, unclear IP protections — sets programs back by years. We have done the identification, audit, and qualification work. We connect you to the right partner and stay engaged to make it work.

What We Do

Four structured engagement areas — from partner selection to long-term operational governance.

🤝 Partner Identification & Due Diligence

Capability mapping against your device specifications
Shortlisting of pre-assessed manufacturing partners
Technical and quality system due diligence
Reference checks and production track record review
Site visit and assessment coordination

🛡 Partner Qualification & Audit

Formal supplier qualification against ISO 13485 requirements
Process audit against product-specific requirements
First Article Inspection (FAI) management
Quality plan and control plan review
GMP and regulatory readiness assessment

💰 Cost Localisation Strategy

Component and sub-assembly localisation opportunities
Make vs. buy analysis for India-sourceable elements
BOM cost reduction without specification compromise
Duty and import optimisation structuring
PLI scheme navigation for eligible device categories

📊 Ongoing Quality & Operational Governance

Regular partner performance monitoring and KPI reporting
Periodic on-site quality audits
CAPA coordination for quality escapes
Change notification and control management
Escalation management between your organisation and the partner

Who This Is For

We serve global device companies at every stage of India market entry and manufacturing scale.

Global device companies entering India manufacturing without local presence

Companies seeking a lower-cost manufacturing base while maintaining quality standards

Organisations requiring a qualified India partner for CDSCO registered manufacturing

Firms with a previous India manufacturing engagement that lacked governance

Why 369 Innovations

We do not make introductions and step away. We qualify the partner, structure the relationship, and remain accountable for performance. Our governance model means you have one point of contact — us — while your manufacturing partner operates to your standards.

Key Differentiator: Vetted partner access plus continuous operational governance — not a one-time introduction.