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R&D & Regulatory Affairs

Attentive to the customer's needs, our R&D team is involved in all the steps of project development : from design to intellectual property
Carrière SD

Industrialization and validation

The development of tools and special machines, followed by complete validation, is carried out by our specialists.
Presse électrique SD


High-performance equipment combined with highly qualified processes guarantee the reliability of our medical devices
SD quality control


A quality policy designed for high and consistent compliance

A multidisciplinary expertise at the service of our partners

The know-how of  SYMATESE DEVICE goes beyond our skills in research, design and development of innovative products in the medical device sector. We manage the entire value chain, including the production and distribution of high quality products in a competitive international environment and in a challenging regulatory context.


R&D & Regulatory Affairs

Bringing your ideas to life

When transforming your needs into products, all our skills are involved. We build a complete solution, from the conception by our R&D department, to the industrialization, qualification and validation, registration and manufacturing of medical devices. We meet our customers' requirements: an optimal reliability of our products to ensure user satisfaction and patient safety.

Our R&D expertise


Modeling and Prototyping


User experience and product risk management


Design the product for manufacturing


Compliance with regulatory requirements

Our multi-disciplinary R&D team will take your project from concept to market, whatever its stage of development. It ensures the expertise needed for successful product design with the support of our experts in manufacturing processes, quality and regulatory affairs. The most critical requirements in terms of manufacturing process qualification and product validation are guaranteed.

Throughout the design and development process, the regulatory affairs team provides compliance with international requirements, for the customer and the notified organizations, and supports the registration process for marketing.

Our R&D resources

Technological excellence is an asset for our developments: we support the evolution of our concepts with resources that allow us to quickly confront the products with reality. We constantly evaluate new technologies and solutions that allow us to integrate added value in your products' functions.


Functional & dimensional validation


Certified partners


Prototype mold, 3D printing, simulation


600 m² of clean room

OUR spirit of innovation

In collaboration with our partners, our teams create original solutions adapted to their specifications.

Creativity is part of our DNA. It is based on the exploitation of our technological platforms and is inspired by emerging trends in the medical device sector, particularly in injectables. Our partnership model guarantees our partners complete confidentiality as well as the rights to exploit innovative solutions.  

Technology plateform

Plastic injection molding allows us to supply a wide variety of polymers.

Polymer processing

In most medical fields, polymers are widely used in the manufacture of medical devices. Symatese Device has developed expertise in the processing of a variety of polymers and produces different delivery systems: high-tech syringes, emergency devices, injectors and their components.

The most used thermoplastics are the following: COC (cyclic olefin copolymer), COP (cyclic olefin polymer), PP (polypropylenes), PE (polyethylenes), PET (polyesters), PC (polycarbonate), ABS (acrylonitrile butadiene styrene), POM (polyoxymethylene), PA (polyamides), PARA (polyarylamide), etc.

Industrialization & validation

The entire industrialization chain is managed to make medical devices available taking account of the constraints linked to the products and their manufacturing environment.

Tooling & Injection

  • Development of plastic injection tools.
  • Technical choices and materials of the moulds studied according to the production environment and the product contact.
  • Wide range of medical grade raw materials and industrial technologies successfully combined.
  • Production of plastic parts in ISO7 room.
  • 100 000h of moulding/year on presses from 40T to 200T.
  • Maintenance of the tools in our workshops for any preventive or curative work.


Développement de machines spéciales automatiques robotisées conçues pour produire en environnement salle blanche ISO7 et répondre à nos différentes technologies.

France Relance



Our technologies

  • Assembling
  • Vision control
  • UV bonding
  • Marking
  • US Welding
  • Packaged in flexible and rigid blister packs
  • Sterilization GAMMA, ETO (subcontracting)

Product validation

Process validation



Injection and tooling workshop
14 moulding machines
In-house tooling workshop
Tool maintenance


Clean room ISO7 650 m2
3 automatic packaging machines
3 sealing machines
Specific assembly and control equipment


1500m² of storage
For management: component/material inputs Finished or semi-finished products from the receiving quarantine area quarantine areas for sterile products


Quality commitment

Quality is at the forefront of all activities at SYMATESE DEVICE. Our overall quality approach and quality policy are designed to ensure constant high quality and compliance on every project, at every stage of the product life cycle. 

SYMATESE DEVICE staff understand that we not only manufacture products, we manufacture components and medical devices that will be used to improve patient's lives.

Group quality policy

SYMATESE is involved in the design and production of innovative medical devices designed to improve the health and quality of life for patients. SYMATESE has chosen to place patients at the center of its Quality Policy. SYMATESE implements effective and efficient Quality Management Systems. 

These systems allow us to design and produce our medical devices in compliance with international regulatory standards and guarantee the quality and safety of our products to patients.

symatese device

As part of our partnership, SYMATESE DEVICE ensures the complete development of your product, writes your technical file ready for registration, and keeps it up to date.