World-First Qualified AM System Sets New Standard for Reproducible On-Demand Manufacturing
The first global case study for Additive Manufacturing (AM) system qualification has been successfully demonstrated at the production site of the toolcraft AG, setting a new benchmark for on-demand compliance of highly critical components in regulated industries.
The transition of Additive Manufacturing from prototyping to high-stakes production in regulated sectors—such as semiconductors, aerospace, medical, and energy—requires state-of-the-art, standardized system qualification. Addressing this need, the Qualified AM (QAM) system has been introduced: a pioneering qualification and monitoring service designed to ensure consistent quality, data-driven validation, and full supply chain traceability.
Toolcraft AG is the first to implement and showcase the QAM AM System in a full-scale operational environment. This milestone signals a new era for scalable AM, combining real-time data insights with rigorous process validation.
1. A New Level of Co-Engineering
The deployment of a Qualified AM system in a certified supply chain enables a paradigm shift in collaborative engineering. Part designers, process engineers, and production teams work within a shared, validated framework. This new level of transparency and control enhances trust, reduces risk, and accelerates the adoption of AM in complex, high-requirement industries.
2. Qualified AM GmbH: Surveillance Audit
At the heart of the QAM system lies a robust surveillance audit mechanism. It systematically assesses machine performance, process consistency, and compliance with regulatory requirements. Unlike one-time validations, this ongoing audit ensures long-term qualification. The result: repeatable, certifiable quality—even in the most demanding applications.
3. Data-Driven System Validation
The QAM system enables data-centric validation by capturing and analyzing key parameters throughout the AM process. Using machine learning and statistical process control, it ensures that each machine setup meets defined performance thresholds. This leads to a faster, more reliable path to production readiness—reducing engineering overhead while increasing transparency for all stakeholders.
4. Supply Chain Monitoring and Capability Transparency
Qualified AM brings end-to-end visibility to the entire supply chain. System status, material batch traceability, and process data are made available to part owners and engineering teams alike. This capability not only supports regulatory compliance but also enables informed decision-making during development and co-engineering.
The implementation of the QAM system marks a significant advancement in the industrialization of additive manufacturing. With standardized qualification, real-time monitoring, and deep data integration, it sets a new benchmark for reliability and scalability in regulated manufacturing environments.
Learn more on: www.Qualifiedam.com
