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OECHSLERhealth qualifies ISO 13485 additive manufacturing line for medical units | VoxelMatters


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OECHSLERhealth, a division of OECHSLER AG specializing in healthcare manufacturing, has achieved full qualification of its first additive manufacturing manufacturing line beneath ISO 13485 requirements. The milestone, reached in August 2025, allows the corporate to ship licensed, end-use parts for regulated medical functions utilizing validated 3D printing processes.

Explore how OECHSLERhealth achieved ISO 13485 qualification to deliver certified components for medical applications. Whereas additive manufacturing has historically been used for prototyping, OECHSLERhealth has expanded its utility to small-series manufacturing in ISO Class 7 and Class 8 cleanrooms. The corporate studies that its licensed services now help medical clients throughout Europe, North America, and the Asia-Pacific area, providing flexibility in scale and growth timelines.

In line with the corporate, additive manufacturing allows shorter product growth cycles, value effectivity for low-volume manufacturing, and constant high quality by means of documented and validated workflows. OECHSLERhealth has been producing 3D printed parts for healthcare since 2023 and continues to concentrate on assembly regulatory and efficiency requirements for medical and industrial use.

“With our expertise and established workflows, we mix medical necessities with additive manufacturing in a single built-in resolution,” the corporate states. “This permits clients to carry compliant, modern merchandise to market extra shortly and reliably.”

OECHSLERhealth supplies contract manufacturing companies for medical units at varied phases, from early prototyping and medical trial provide to high-volume manufacturing. The corporate emphasizes its capability to ship custom-made options that meet Good Manufacturing Follow (GMP) pointers and regional regulatory necessities.

Based greater than 30 years in the past, OECHSLER AG has constructed its healthcare unit to function a long-term companion for medical machine builders, specializing in affected person outcomes and scalable innovation.

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