Project Approval
From Concept
to Reality

Creating & innovating medical devices for a better quality of life

Project Approval
From Concept
to Reality

Creating & innovating medical devices for a better quality of life

Why Milestone 1
Product Approval
Matters?

Milestone 1 represents the transition from system architecture to fully engineered product realization.

The Challenge:
Transforming a defined system architecture into a complete, validated product requires the seamless integration of industrial design, mechanical and electronic systems, and software components—while ensuring performance, usability, and technical feasibility are fully verified.

Our Approach:
We refine the industrial design, engineer mechanical and electronic systems, and develop functional prototypes to verify performance, usability, and technical feasibility. Our multidisciplinary teams across Design Engineering, Hardware/Firmware/Software, Usability Engineering, and Prototyping integrate all product subsystems into a complete, fully engineered solution.

Outcome:
Completion of this milestone confirms that the product has been verified and documented within a Design Master Record (DMR), establishing a controlled foundation for design transfer and manufacturing scale-up.

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

Industrial Design & Branding

The heart of
Our Creation Process

Branding &
Family Feeling

We ensure the product aligns with your brand identity and fits perfectly within your existing product lineup

Industrial
Design

Balancing ergonomics, aesthetics, user-centric features and feasibility to show the design concept for your product

Packaging
& Label Definition

Designing the full unboxing experience, from protective casing to regulatory labeling

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

 

Product Engineering

YourDesign is refined.
YourEngineering is solid.

Mechanical
System
Engineering

Developing and formally validating the device’s mechanical systems to meet performance, cost, and manufacturability requirements while ensuring seamless integration with all subsystems

Product
Engineering
Definition

Integrating concept, mechanical, and HW/FW/SW systems into a validated, cost-effective, and manufacturable device that meets performance and project requirements

SW/HW
Electronics
& App’s

Custom circuit design and mobile/web application development tailored to your device hardware

Design for
Manufacturing &
Assembly

Engineering every part specifically to be easy and sustainable to produce

Quality & Production Strategy

TheApproval Ready
Guarantee

By the time, your product has survived rigorous Usability Testing and technical scrutiny.
You aren’t just approving a drawing; you are approving a fully engineered system ready for the factory floor

Design
History File
(DHF)

We maintain a rigorous DHF, ensuring every design decision is documented for regulatory compliance (ISO/MDR)

Quality
Control

Implementing standardized checks to ensure the prototype meets the high-level inputs defined during Milestone 0

Tooling
Definition &
Q-CM Estimation

Setting the stage for production by defining your tooling requirements and estimating contract manufacturing costs

Milestone 1 - Product Approval

Visualize.
Interact.
Approve.
Bring Your Product to Life.

Contact us ofr Create & innovate together your next project

Unlock the Next Milestone

Ready for
Design & Development Transfer?

Discovery Milestone 2 - Design Freeze

Creanova S.r.l.     Via Antonio Magni 54, 22100 Como, Italy   VAT: IT 03103770131   SDI: UPAL8PV

Creanova and Creaproduct – Italy e Creanova doo – Serbia are part of Creagroup

Creanova S.r.l.     Via Antonio Magni 54, 22100 Como, Italy   VAT: IT 03103770131   SDI: UPAL8PV

Creanova and Creaproduct – Italy e Creanova doo – Serbia are part of Creagroup

Creanova S.r.l.     Via Antonio Magni 54, 22100 Como, Italy   VAT: IT 03103770131   SDI: UPAL8PV

Creanova and Creaproduct – Italy e Creanova doo – Serbia are part of Creagroup