WhyMilestone 2
Design Freeze to
Manufacturing Release
Matters?
We bridge the critical transition between finalized product design and manufacturing implementation. From Design Freeze through Manufacturing Release, we ensure your product is fully defined, production-ready, and compliant with all regulatory and quality requirements.
The Challenge:
Transitioning from development to production requires complete technical documentation, defined manufacturing processes, and strict control of product specifications to ensure consistent and repeatable production.
Our Approach:
At Design Freeze, all product specifications and technical documentation are formally approved and released. We then execute a structured Design Transfer process, ensuring manufacturing processes, tooling, and quality controls are fully aligned with the approved design.
Outcome:
This milestone ensures your product is ready for reliable, scalable, and compliant manufacturing.
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
Technical Industrialization
Transition from
Project to Product
Tooling Contract
Manufacturer
Providing technical oversight and coordination with tooling manufacturers to ensure molds and equipment fully comply with the approved tooling specifications and product requirements
First Out
of Tool
Performing dimensional, functional, and quality verification of initial molded components to confirm conformity with design specifications and readiness for production
Mold Flow
& DFM/DFA
Conducting mold flow analysis and Design for Manufacturing and Assembly (DFM/DFA) optimization to ensure robust production processes and minimize manufacturing risks
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
Quality & Process Validation
Validated Production
Locked Quality
IQ/OQ/PQ
Qualifying equipment and manufacturing processes through Installation, Operational, and Performance Qualification to ensure consistent, controlled, and repeatable production
Design
Master Record
(DMR)
Establishing the formally approved and controlled set of documentation defining product specifications, manufacturing processes, quality controls, and production requirements
Process
Validation
Validating manufacturing processes to demonstrate they consistently produce products meeting predetermined specifications and quality requirements
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
Supply Chain & Assembly
Launch Full-Scale
Serial Production
Purchasing
Process & Setup
Establishing and controlling the supply chain through qualified suppliers and procurement processes to ensure consistent material availability and uninterrupted production
Assembly
Verification
Verifying assembly processes, equipment, and work instructions to ensure consistent, repeatable, and compliant product assembly
Market
Ready Status
With design and process validation completed, the product is formally released for full-scale commercial production
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