OUR SKILLS
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We design, manufacture, and market medical devices that are minimally invasive, reversible, and aimed at improving the patient's life.
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We are looking for innovation in terms of products and production processes.
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We develop skills and know-how to move from the idea to the market in the shortest possible circuit.
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We carry out our activity with a view to efficiency, the well-being of staff, and by seeking to limit our environmental impact.
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We favor Made in France suppliers and manufacturing whenever possible.
HELIOSCOPIE controls all of the manufacturing of its products, from delivery of the raw material to shipment to our customers.
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Our productions
Our manufacturing is carried out in cleanrooms to control particulate or biological contamination. The production site is qualified annually according to 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 cleanrooms, 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 products are CE marked according to the European regulations in force.
Our expertise
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Study and development of products and/or processes until they are placed on the market.
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Cleanroom manufacturing, from materials that can be implanted in the short or long term.
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Molding of silicones.
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Metal/silicone/polymer assembly (gluing and welding in particular).
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Clean blister packaging.
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Steam (internal) and ethylene oxide (sub-processed) sterilisation.
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Quality and Regulatory engineering for the approval of Medical Devices in France and abroad.
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Clinical studies in France or abroad.
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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