{"id":249933,"date":"2022-10-18T10:36:50","date_gmt":"2022-10-18T08:36:50","guid":{"rendered":"https:\/\/symatese-device.com\/?page_id=249933"},"modified":"2023-10-10T14:36:28","modified_gmt":"2023-10-10T12:36:28","slug":"expertise","status":"publish","type":"page","link":"https:\/\/symatese-device.com\/en\/expertise\/","title":{"rendered":"Expertise"},"content":{"rendered":"
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R&D & Regulatory Affairs<\/h1>

Attentive to the customer's needs, our R&D team is involved in all the steps of project development : from design to intellectual property<\/h5> \n\n\t\t\t\t\t\t
Read more<\/a>\t\t\t\t\t\t<\/div><\/div>\n\t\t<\/div>\n\t\t\t<\/div>\n<\/div>\n\n
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Industrialization and validation<\/h1>

The development of tools and special machines, followed by complete validation, is carried out by our specialists.<\/h5> \n\n\t\t\t\t\t\t
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Manufacturing<\/h1>

High-performance equipment combined with highly qualified processes guarantee the reliability of our medical devices<\/h5> \n\n\t\t\t\t\t\t
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Quality<\/h1>

A quality policy designed for high and consistent compliance<\/h5> \n\n\t\t\t\t\t\t
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A multidisciplinary expertise at the service of our partners<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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The know-how of\u00a0SYMATESE DEVICE<\/strong>\u00a0SYMATESE 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.<\/p>

\u00a0<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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R&D &<\/span> Regulatory Affairs <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Bringing your ideas to life<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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notre expertise r&D<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\n\t\t\t\t\t\tERGONOMIC ENGINEERING\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\tUser experience and product risk management\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\tPRODUCT ENGINEERING\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\tDesign the product for manufacturing\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\tREGULATORY AFFAIRS\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\tCompliance with regulatory requirements\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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nos moyens r&d<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\t\t\tR&D LAB\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\tFunctional & dimensional validation\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\u00c9VALUATION CLINIQUE & BIOLOGIQUE\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\tCertified partners\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\tFAST PROTOTYPE\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\tPrototype mold, 3D printing, simulation\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\tISO7 & CENTRE D'ESSAI\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t600 m\u00b2 of clean room\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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OUR spirit of innovation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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In collaboration with our partners, our teams create original solutions adapted to their specifications.<\/p>

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. \u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Technology<\/span> plateform<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Plastic injection molding allows us to supply a wide variety of polymers.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Polymer processing<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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.<\/p>

The most used thermoplastics are the following: COC<\/strong> (cyclic olefin copolymer), COP<\/strong> (cyclic olefin polymer), PP<\/strong> (polypropylenes), PE<\/strong> (polyethylenes), PET<\/strong> (polyesters), PC<\/strong> (polycarbonate), ABS<\/strong> (acrylonitrile butadiene styrene), POM<\/strong> (polyoxymethylene), PA<\/strong> (polyamides), PARA<\/strong> (polyarylamide), etc.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Industrialization &<\/span> validation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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The entire industrialization chain is managed to make medical devices available taking account of the constraints linked to the products and their manufacturing environment.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Tooling & Injection<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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  • Development of plastic injection tools.<\/li>
  • Technical choices and materials of the moulds studied according to the production environment and the product contact.<\/li>
  • Wide range of medical grade raw materials and industrial technologies successfully combined.<\/li>
  • Production of plastic parts in ISO7 room.<\/span><\/li>
  • 100 000h of moulding\/year on presses from 40T to 200T.<\/li>
  • Maintenance of the tools in our workshops for any preventive or curative work.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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    Industrialization<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Development of specific automatic robotic machines designed to produce in an ISO7 clean room environment and to meet our different technologies<\/p>

    \"France<\/p>

    \u00a0<\/p>

    \u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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    \n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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    Our technologies<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    • Assembling<\/li>
    • Vision control<\/li>
    • UV bonding<\/li>
    • Marking<\/li>
    • US Welding<\/li>
    • Packaged in flexible and rigid blister packs<\/li>
    • Sterilization GAMMA, ETO (subcontracting)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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      Product validation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      \n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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      Process validation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      \n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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      <\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Manufacturing<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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      <\/div>\n\t\t\t\t
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      \n\t\t\t\t\t\tINJECTION WORKSHOP\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
      \n\t\t\t\t\t\tInjection and tooling workshop<\/br>\n\n14 moulding machines<\/br>\n\nIn-house tooling workshop<\/br>\n\nTool maintenance<\/br>\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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      <\/div>\n\t\t\t\t
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      \n\t\t\t\t\t\tWHITE ROOM\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
      \n\t\t\t\t\t\tClean room ISO7 650 m2<\/br>\n\n3 automatic packaging machines<\/br>\n\n3 sealing machines<\/br>\n\nSpecific assembly and control equipment<\/br>\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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      <\/div>\n\t\t\t\t
      <\/div>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t
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      \n\t\t\t\t\t\tSTORE\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
      \n\t\t\t\t\t\t1500m\u00b2 of storage<\/br>\n\nFor management:\n\ncomponent\/material inputs\n\nFinished or semi-finished products\n\nfrom the receiving quarantine area\n\nquarantine areas for sterile products\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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      <\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Quality<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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      Quality commitment<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      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.<\/span>\u00a0<\/span><\/p>

      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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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      Group quality policy<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      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.<\/span>\u00a0<\/span><\/p>

      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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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      symatese device<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      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.<\/p>

      \"\"<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

      R&D & Affaires r\u00e9glementaires L\u2019\u00e9quipe R&D \u00e0 l\u2019\u00e9coute du client r\u00e9alise tous les stades du d\u00e9veloppement projet : de la conception \u00e0 la propri\u00e9t\u00e9 intellectuelle En savoir plus Industrialisation et validation La mise au point des outillages et des machines sp\u00e9ciales, suivi d\u2019une validation compl\u00e8te, est assur\u00e9e par nos sp\u00e9cialistes En savoir plus Production Des […]<\/p>\n","protected":false},"author":13,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-249933","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/symatese-device.com\/en\/wp-json\/wp\/v2\/pages\/249933","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/symatese-device.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/symatese-device.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/symatese-device.com\/en\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/symatese-device.com\/en\/wp-json\/wp\/v2\/comments?post=249933"}],"version-history":[{"count":20,"href":"https:\/\/symatese-device.com\/en\/wp-json\/wp\/v2\/pages\/249933\/revisions"}],"predecessor-version":[{"id":252715,"href":"https:\/\/symatese-device.com\/en\/wp-json\/wp\/v2\/pages\/249933\/revisions\/252715"}],"wp:attachment":[{"href":"https:\/\/symatese-device.com\/en\/wp-json\/wp\/v2\/media?parent=249933"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}