Medical Device Engineering can propose you a complete project management allying technical and scientific skills.


We may as well operate at any of below steps depending on your need, and the progress of your project.


As a first step, the exact DEFINITION OF THE NEED is documented through a FUNCTIONAL ANALYSIS of the product & from its expectations (Patient, User, Market...)

All output data of this phase are merged into a PRE-DESIGN study validated with you, which is the base we will start CAD work from.

As this pre-design is frozen, we can start with the CAD CONSTRUCTION of the parts.

The CAD DEFINITION OF THE ASSEMBLING is handled in parallel, so that each part's DESIGN ADAPTATIONS can stick closely to both final requirements of the product, & manufacturing methods...

The PROTOTYPE PHASE aims to challenge &/or confirm the technical choices made in terms of design.

Through DESIGN REVIEWS, we analyze whether all the functionalities are met or not. If not fully, they are mocked up & challenged until the PROOF OF CONCEPT is done.

Depending on your products & Business plan, TECHNICAL & ECONOMICAL OPTIONS are analyzed together to offer you the best choice in terms of industrial investment.

We handle the MOULDS SPECIFICATION, and the STUDIES VALIDATION with our network of toolmakers in Europe & in Asia. We target the most suitable to your products amongst them...

When needed, we can offer you a PILOT MOULD phase, prior to SERIAL PRODUCTION MOULDS.

We insure of course the MOULD CONSTRUCTION FOLLOW UP, and we are present on site (Europe / Asia) for the TRIALS & TUNING STEPS. The FINAL RECEPTION of the moulds is managed together with you.

Our Experience & expertise in the medical device manufacturing industry allow us to support you during the INDUSTRIALIZATION of your products.

From PROCESS QUALIFICATIONS, CLEANING VALIDATION, STERILIZATION, to the SELECTION OF YOUR SUBCONTRACTORS...

Beside the technical path of your development, we can integrate both Validation & Regulatory aspects :


✓ Regulatory requirements depends as much on your business plan (export destination...), than on your product itself : Therefore, they must be taken into account from the very beginning.

✓ For this reason, we can offer you to manage the constitution of your technical file (CE mark, FDA registration...), starting from the functional analysis of your device during design step.

✓ As well, our double competence allows us to manage fully your in vivo, &/or in vitro, &/or clinical trials, function of the classification of your device.



Medical Device Engineering can also support companies with injection molding issues and injection molding integration target.



Due to the strict confidentiality policy applied by Medical Device Engineering, we are limited to display products pictures. Please do not hesitate to contact us to discuss more into details about our experiences & past developments.