At a glance
| Booth | R7112 |
| Country | DE |
| Website | qualifiedam.com |
Company profile
Qualified AM GmbH brings more than 30 years of hands-on additive manufacturing experience to qualification, certification, digital quality management and production-readiness work. Before additive manufacturing was broadly industrialized, team members were already helping build some of the world’s first serial AM production environments. Work across medical, dental and industrial applications gave the team practical experience in process validation, material qualification, production stability, regulatory compliance and manufacturing scale-up. The company reports practical industrial knowledge from production environments in Europe, North America, Asia, India and Australia. From 2017 to 2022, its experts contributed within ISO/ASTM TC 261 and helped develop internationally recognized additive-manufacturing qualification frameworks. Named contributions include DIN SPEC 17071, ISO/ASTM 52920, ISO/ASTM 52939, ISO/ASTM 52964 and multiple ISO/ASTM joint groups focused on AM qualification. Qualified AM GmbH was established during the 2022 to 2025 period to make industrial additive-manufacturing qualification accessible, scalable and trustworthy. Its combined expertise includes qualification and audits, standards and certification, supply-chain qualification, digital quality management and industrial production readiness. The company states that it supports organizations in semiconductor, rail, medical, aerospace, defense and energy and connects manufacturers, certification bodies, regulators and customers. From 2026 onward, Qualified AM is developing QamX®, a digital platform intended to qualify, assess and continuously improve manufacturing readiness. QamX supports qualification of production lines, equipment, materials, parts, quality systems and supply chains, with the goal of making qualification knowledge scalable, consistent and audit-ready. The company describes a collaborative certification approach that guides customers through qualification, explains deviations and works with them toward defined goals. Its stated experience includes building serial AM production environments, helping develop international qualification standards, qualifying industrial manufacturing processes, auditing manufacturers worldwide, supporting regulated industries, developing digital qualification technologies and connecting global supply chains. Qualified AM states that a fully qualified production line can typically be established within 3 months depending on readiness and resources, while larger projects usually take 6 months from Phase 0 goal setting to Phase 5 certification. For ISO/ASTM 52920 implementation, the company cites 155 mandatory requirements and positions its support around applying the standard for continuous improvement and compliance. Qualified AM offers training programs and workshops for certification readiness so staff can understand certification requirements and prepare for audits. It explains that AM qualification must control process variables across anisotropic behavior, multistep process chains, sensitive feedstock management and intensive human involvement to achieve necessary part quality. The company also states that certification applies to the AM systems, materials and process parameters intended for production and can coexist with non-certified processes.
Exhibits
The standardized Qualified AM Program is designed to enable growth and scalability in additive manufacturing by preparing manufacturers to establish qualified processes for regulated and demanding industries. The program begins with 1 to 2 weeks for defining a standards-aligned qualification scope linked to relevant ISO/ASTM frameworks. In the first month, a QamX-supported status-quo assessment reviews current systems, processes and the quality framework, identifies gaps and provides a roadmap toward Stage 1 audit readiness. Ramp-up support runs through months 1 to 3 with hands-on guidance for implementing changes and optimizing processes for compliance and performance. The Stage 1 audit is listed in month 4, followed by gap-closing support in month 5 and a comprehensive Stage 2 audit in month 6. Certification is listed for month 7 after successful completion of Stage 2, confirming that the additive-manufacturing processes meet the required industry standards. The service portfolio includes additive-manufacturing risk assessment and pFMEA, readiness checks, custom working instructions, quality-management-system implementation and documentation support, validation planning, tailored use-case consultation, life-cycle assessment, production-performance review, health and safety assessment, and business-model coaching. The company describes its goal as helping organizations address AM-production complexity, regulatory compliance and operational efficiency with tailored knowledge, tools and strategies for long-term scalability and growth. QamX® is presented as Software as a Service for AM Qualification. The software is designed to identify, evaluate and mitigate AM-specific risks in real time, automate documentation, approvals and updates with AI-driven workflows, and provide traceability and evidence packs for processes. QamX supports engineering and qualification services, equipment and materials, part-specific production lines, generic production lines, and supply-chain or supplier qualification. The platform is described as accelerating qualification and compliance for additive-manufacturing equipment, processes, materials and parts across regulated industries, with AI-powered software for global standards, risk mitigation and pFMEA strategies. QamX-QMS supports digital, audit-ready quality-management-system documentation, including automatic generation of QMS documents and compliance reports, links between manufacturing plans and ISO/ASTM standards, integrated SOPs, checklists and workflows, and automated alerts. Its risk-management functions include scalable pFMEAs, AM-specific ISO/ASTM risk libraries, AI-suggested mitigations and compliance actions, and QMS-linked traceable documentation. Supply-chain functions include a directory of certified AM suppliers, filtering by process, material and compliance, RFQ management with traceability and collaboration on qualification plans. On-demand digital compliance functions cover part and process qualification, certification and audits, guided audit-ready documentation, and synchronization with QamX RISK and QMS. Supported AM standards listed by the platform include ISO/ASTM 52900, 52901, 52902, 52904, 52905, 52906, 52907, 52908, 52910, 52914, 52915, 52920, 52928, 52930, 5293, 52939, 52941 / 52942, 52954 and 52964. Organizational standards listed include ISO 9001, ISO 13485 and AS/EN 9100, while industry standards and regulations include NASA-STD-6030, ECSS-Q-ST-70-80C, DNV-ST-B203 and the Pressure Equipment Directive. QamX is presented for rail, semiconductor, medical, energy, food, construction, aviation, space, research and automotive use, with role-based functions for supply-chain managers, quality managers, and process and operations engineers. The software tiers are TRACE, MANAGE, PRODUCE and SCALE, ranging from free supply-chain visibility to enterprise-level quality and production planning with multi-site and critical-industry control requirements. Qualified AM also identifies a semiconductor-industry milestone as the world’s first qualified supply chain for the semiconductor industry, ASML.
Capabilities and products
- additive manufacturing qualification and audits
- additive manufacturing supply-chain qualification
- AM equipment qualification
- AM material qualification
- AM quality-system qualification
- QamX® SaaS for AM qualification
- Identify, evaluate, and mitigate AM-specific risks in real time.
- pFMEA risk analysis for AM processes
- On-demand part and process qualification