Why Milestone 3
Device Delivery Matters?
Milestone 3 represents the transition from validated production to full-scale commercial manufacturing and global product delivery. The focus is on maintaining process control, product consistency, and full regulatory compliance throughout production and distribution.
The Challenge:
Scaling manufacturing while ensuring consistent product quality, traceability, and compliance with all regulatory and quality requirements.
Our Approach:
A fully validated and controlled manufacturing system, supported by qualified equipment, validated processes, and strict adherence to the Design Master Record (DMR).
Outcome:
Consistent, compliant, and scalable production, enabling reliable product delivery and optimized time-to-market.
Three Pillars
of Definition
Design &
Development
Expertise team:
Product Engineering
HW/FW/SW
Usability D&E
Prototype
Quality
Management
Expertise team:
ISO 13485
Quality Control
Verification & Validation
Regulatory Support
Mass
Manufacturing
Expertise team:
Supply chain
Tooling
Pre series
Manufacturing
Advanced Fabrication & Assembly
From
Components to
Finished Device
Plastic
Injection Moulding
Precision injection moulding utilizing validated tooling, controlled process parameters, and qualified materials to ensure consistent, compliant component production
Electronic &
Product Assembly
Assembly of electronic and electromechanical devices within controlled manufacturing environments, following approved work instructions and quality control procedures
Clean Room
Operations
Medical device manufacturing and assembly conducted in controlled cleanroom environments in accordance with applicable environmental and contamination control standards
UX/UI
& Interactive
Prototyping
Don’t just look at a screen experience the digital interface in a clickable, high-fidelity environment
Usability
Test
We put the product in the hands of users early to refine and perfect the experience
Global Supply Chain & Logistics
The final
fulfillment of the
Product Vision
Supply Chain
Continuity
Managing qualified suppliers and controlled procurement processes to ensure consistent material availability and uninterrupted manufacturing
Logistics &
Distribution
Executing controlled storage, handling, and global distribution of finished medical devices, ensuring full traceability and regulatory compliance
Production
Ready Status
Maintaining validated production processes and operational readiness to support reliable, scalable, and compliant product delivery
UX/UI
& Interactive
Prototyping
Don’t just look at a screen experience the digital interface in a clickable, high-fidelity environment
Usability
Test
We put the product in the hands of users early to refine and perfect the experience