A Unique Methodology Rooted in 20 Years of Expertise

1. Proof of Concept

Giving birth to innovation

We elaborate from your idea (a scheme, a patent, a concept…) and translate it into physical prototypes in order to evaluate proof of concept

Key Highlights:

• Straight to purpose as fast as possible.

• Swift and Streamlined design with R&D tools and equipments.

How It Works:

This phase focuses on demonstrating the feasibility of the idea, will it be manufacturable? How does it serve the user needs?

Develop / manufacture / Test early prototypes

2. Project Launch and Design Inputs

Laying the Foundation for Success

We establish a Design History File (DHF) and a comprehensive Device Development Plan (DDP), tailored to your project’s needs. We work on User needs and technical requirements and early regulatory frameworks.

Key Highlights:

• Definition of clear project objectives and deliverables.

• Strategic alignment with regulatory requirements.

How It Works:

This phase focuses on planning and preparation, setting a clear roadmap to guide the project through its critical stages while addressing potential risks early on.

-Product development plan
- User needs to Design input requirements
- risk analysis process
- Construct regulatory framework

3. Design & Development Management

Turning Concepts into Designs

We really turn to a structured development of your device, supported by design iterations, testing and impact analyses.

Key Highlights:

• Iterative design process to refine concepts.

• Regular reviews to maintain alignment with objectives.

How It Works:

Our team collaborates with yours to transform ideas into validated designs, leveraging systematic methods to ensure precision and adaptability throughout the process.

-Develop one or more design / drawing(s)
-Manufacture prototype(s)
-Test prototype(s)

4. Verification and Validation

Ensuring Safety, Meeting expectations, Fulfilling needs.

After a thorough VnV plan, we support you in the demonstration of safety, effectiveness and reliability of your design in preclinical and clinical environments.

Key Highlights:

• Ensures that the design output matches the design input

• Ensures the device meets user’s needs and intended use in real-world conditions

How It Works:

Our team manages expert partners in protocols, testing, inspection and documentation of your device against technical and clinical specifications, standards requirements, usability and reliability of the manufacturing process

- tests & analysis to verify requirements are fulfilled by the chosen solution
- Perform tests and analysis to verify that the user needs are fulfilled by the chosen solution

5. Technical Documentation

Navigating the Approval Process with Expertise

This critical phase prepares your device for market entry by ensuring it meets all technical regulatory requirements.

Key Highlights:

• Expert preparation of submission documents.

• Alignment with international compliance standards.

How It Works:

We streamline the submission process to minimize delays, ensuring your device achieves certification efficiently and effectively

- Gather plans, documents & reports to demonstrate compliance to regulatory requirements

6. Production & Market Launch

Bringing Your Vision to Life

The final phase focuses on production readiness and successful market introduction.

Key Highlights:

• Validated production processes.

• Comprehensive support for market entry.

How It Works:

From scaling up production to launching your product, we ensure a smooth transition, setting the stage for long-term success.

- DMR (manufacturing specifications, in process or final controls, BoM…) writing
- Manufacturing Process validation
- Transfer of the documentation to the production
- Construction of the regulatory documentation
- FInalize development process