Saturday, November 29, 2025

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 below ISO 13485 requirements. The milestone, reached in August 2025, permits the corporate to ship licensed, end-use parts for regulated medical purposes utilizing validated 3D printing processes.

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 experiences 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 response to the corporate, additive manufacturing permits 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 deal with assembly regulatory and efficiency requirements for scientific and business use.

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

OECHSLERhealth gives contract manufacturing companies for medical units at numerous phases, from early prototyping and scientific 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 system builders, specializing in affected person outcomes and scalable innovation.

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