The manufacturing of silicone components, sub-assemblies and medical devices requires production environments adapted to the criticality level of each application.
EXSTO has ISO 6, ISO 7 and ISO 8 classified cleanrooms, as well as non-classified clean environments, to meet the cleanliness, quality, traceability and compliance requirements of the medical sector.
ISO 6
ISO 7
ISO 8
Beyond industrial capabilities, our teams support projects with a focus on risk control, process validation and documentation adapted to the requirements of medical devices.
Contact a Medical expertEnvironments adapted to every level of requirement
Depending on the type of device, its intended use, class, criticality level and production constraints, EXSTO guides each project towards the most suitable environment: classified cleanroom, non-classified clean environment or dedicated production area.
This approach helps align quality requirements, industrial constraints and the economic feasibility of the project.
Quality and traceability
Our processes are designed to ensure the traceability of materials, components, operations and inspections carried out throughout the production chain.
This control helps secure medical projects, facilitate quality discussions with customers and provide the necessary elements for qualification or validation files.
Qualification support
EXSTO is ISO 9001 and ISO 13485 certified and supports its customers on key qualification elements: process validation, final inspections, metrology, development of specific test benches, data for regulatory files and support during customer audits.
The objective: to provide a reliable, documented industrial framework, aligned with the expectations of the medical sector.
EXSTO: a trusted CSMO partner
Medical News
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Health/Medical, Industrial Processes • The 22 June 2026 EXSTO designs and manufactures extruded silicone profiles, tubes and cords, available as standard or custom-made solutions, to meet the needs of medical, pharmaceutical, industrial and technical applications. Whether you need a silicone tube, a silicone cord, a solid profile, a hollow profile or a specific cross-section developed from a drawing, our teams adapt the material, geometry, dimensions and finishing operations to your application requirements.
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Health/Medical • The 2 October 2025 Silicone expertise at the service of mothers of premature babies
New article in the September/October 2025 issue of the Device Med magazine
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Health/Medical • The 3 October 2025 Complex medical devices: a new standard?
Innovation in the healthcare sector is driving medical devices to achieve higher levels of performance, precision… and complexity. But what does “complex” really mean in this context?