OECHSLERhealth qualifies ISO 13485 additive manufacturing line for medical devices

OECHSLERhealth, a division of OECHSLER AG specializing in healthcare manufacturing, has achieved full qualification of its first additive manufacturing production line under ISO 13485 standards. The milestone, reached in August 2025, enables the company to deliver certified, end-use components for regulated medical applications using validated 3D printing processes.

While additive manufacturing has traditionally been used for prototyping, OECHSLERhealth has expanded its application to small-series production in ISO Class 7 and Class 8 cleanrooms. The company reports that its certified facilities now support medical customers across Europe, North America, and the Asia-Pacific region, offering flexibility in scale and development timelines.

According to the company, additive manufacturing enables shorter product development cycles, cost efficiency for low-volume production, and consistent quality through documented and validated workflows. OECHSLERhealth has been producing 3D printed components for healthcare since 2023 and continues to focus on meeting regulatory and performance standards for clinical and commercial use.

“With our experience and established workflows, we combine medical requirements with additive manufacturing in a single integrated solution,” the company states. “This enables customers to bring compliant, innovative products to market more quickly and reliably.”

OECHSLERhealth provides contract manufacturing services for medical devices at various stages, from early prototyping and clinical trial supply to high-volume production. The company emphasizes its capacity to deliver customized solutions that meet Good Manufacturing Practice (GMP) guidelines and regional regulatory requirements.

Founded more than 30 years ago, OECHSLER AG has built its healthcare unit to serve as a long-term partner for medical device developers, focusing on patient outcomes and scalable innovation.