Medical-Grade Manufacturing. From First Build to Full Scale.

Prototype to production — controlled, compliant, on time. We close the gap between a functional prototype and a manufacturable product through structured build phases, validated processes, and disciplined documentation.

The Problem We Solve

A functional prototype is not a manufacturable product. The gap between the two — undefined processes, unqualified suppliers, untested assembly — is where most device programs lose six to eighteen months. We close that gap through structured build phases, validated processes, and disciplined documentation so your device enters volume production ready for regulatory scrutiny.

What We Do

Five manufacturing disciplines — executed with full regulatory documentation rigor.

🏗 EVT / DVT / PVT Build Management

Engineering Verification Test (EVT) build planning and execution
Design Verification Test (DVT) build with production-intent processes
Production Verification Test (PVT) — final pre-launch validation build
Build failure analysis and design feedback loop
Build records and full traceability documentation

🏭 Low-to-Mid Volume Production

Production planning for 100 to 50,000+ units per year
Work instruction development and operator qualification
Process validation: IQ, OQ, PQ
Production efficiency and yield monitoring
Scalable line expansion planning aligned to commercial ramp

🔗 Supply Chain & Vendor Qualification

BOM optimisation and sourcing strategy
Approved Vendor List (AVL) development
Supplier qualification audits
Component lead time and buffer stock management
Alternate sourcing for critical and long-lead components

🧪 Functional Testing, Calibration & QC

Functional test fixture design and build
Electrical and mechanical calibration procedures
In-process quality control and AQL sampling
Device History Record (DHR) management
Outgoing QA and Certificate of Conformance documentation

📦 Packaging, Labeling & Regulatory Documentation

Packaging design and material qualification
Labeling per FDA 21 CFR Part 801, EU MDR Annex I, and CDSCO requirements
Shelf life and accelerated aging study support
Sterile packaging validation where applicable
Shipping and transport validation per ISTA/ASTM standards

Who This Is For

We work with device companies at every stage of the manufacturing journey.

Companies transitioning from prototype to clinical-grade production

Device makers needing a qualified India-based CMO with full regulatory documentation capability

Firms whose current manufacturer cannot meet FDA or CE documentation requirements

Companies scaling volume after market clearance

Why 369 Innovations

We do not just manufacture — we manufacture with the documentation discipline that regulatory bodies and auditors require. Every build phase produces records your regulatory team can trace, your QMS can reference, and your auditors can inspect. That is what medical-grade contract manufacturing means.

Key Differentiator: Manufacturing executed with regulatory documentation rigor — not added after the fact.