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OUR SKILLS

  • We design, manufacture, and market medical devices that are minimally invasive, reversible, and aimed at improving the patient's life.

  • We are looking for innovation  in terms of products and processes torealization.

  • We develop skills and know-how to move from the idea to the market in the shortest possible circuit,

  • We carry out our activity with a view to efficiency, the well-being of staff, and by seeking to limit our environmental impact.

  • We favor Made in France suppliers and manufacturing whenever possible.

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HELIOSCOPIE controls all of the manufacturing of its products, from delivery of the raw material to shipment to our customers.

Our productions

Our manufacturing is carried out in a controlled atmosphere zone to control particulate or biological contamination. The production site is qualified annually according to the requirements imposed by the European CE marking directives and our quality system. The people involved in the manufacturing process undergo specific training in the manufacturing processes, its control in a controlled atmosphere zone, and in the quality and regulatory requirements.

 

The company also has a panel of qualified and certified subcontractors for our activity in the medical field. HELIOSCOPIE's quality management system benefits from EN ISO 13485 certification and all of its ranges are CE marked according to the European regulations in force.

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Our expertise

  • The study and development of products and/or processes until they are placed on the market.

  • The mastery of manufacturing in a controlled atmosphere environment, from materials that can be implanted in the short or long term.

  • The molding of silicones.

  • The metal / silicone / polymer assembly (gluing and welding in particular).

  • Clean blister packaging.

  • Steam (internal) and ethylene oxide (sub-processed) sterilization.

  • Quality and Regulatory engineering for the approval of Medical Devices in France and abroad.

  • The conduct of clinical studies in France or abroad.

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Marketing & Distribution

Helioscopie has a national sales network. In direct contact with digestive, bariatric, uro-gynecological surgeons and gastroenterologists, our sales force has all the qualities required in these specialties to support health professionals in compliance with regulatory requirements.

 

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