Standards-Based and Senior Expert-Audited Risk Assessment according to ISO/ASTM 52920, ISO/ASTM 52954, ISO/ASTM 52904, ISO 14971, ISO 13485 and AS9100
Transform your risk assessments from static spreadsheets into a living qualification intelligence system.
The Qualified AM team performs risk assessments and pFMEAs for additive manufacturing based on internationally recognized standards, industry best practices, and years of hands-on qualification, auditing, certification, and manufacturing experience.
Our methodology combines standards-based risk assessment with senior expert-audited failure mode libraries developed from real-world qualification projects across medical devices, aerospace, defense, semiconductor, energy, and industrial manufacturing.
QamX RISK evaluates risks across the complete Scope of Qualification, including:
- Materials
- Equipment and machine configurations
- Process parameter windows
- Manufacturing environments
- Supply chains and suppliers
- Part criticality and intended application
Unlike conventional FMEAs, failure modes are not created in isolation. Every failure mode is continuously referenced against applicable additive manufacturing standards, qualification requirements, regulatory expectations, lessons learned, and best practices from both additive and conventional manufacturing technologies.
This ensures that risk assessments are based on recognized industry knowledge, auditor expertise, and proven qualification methodologies rather than subjective assumptions.
Powered by QamX RISK, risks are directly linked to:
- Qualification requirements
- Verification and validation activities
- Test plans and acceptance criteria
- Audit evidence and CAPAs
- Certification requirements
- Surveillance audits
- Requalification activities
- Certification scope extensions
The result is a continuously improving, expert-governed qualification intelligence system that enables scalable, traceable, and regulator-ready risk management.
Key Benefits
- Standards-based and senior expert-audited methodologies
- ISO/ASTM 52920, 52954, 52904 and ISO 14971 aligned
- Deep additive manufacturing qualification expertise
- Auditor-reviewed failure mode libraries
- Reusable qualification evidence and lessons learned
- Faster qualification and certification projects
- Improved audit readiness and regulatory compliance
- Scalable governance across products, sites, and suppliers
QamX RISK transforms pFMEA from a static risk assessment into a living qualification intelligence system.
Built on internationally recognized standards, auditor expertise, and continuously evolving failure mode libraries, QamX enables organizations to identify, assess, mitigate, and govern risks with confidence.
By linking risks directly to qualification activities, audit evidence, validation plans, and certification requirements, QamX provides the trusted foundation required for qualification approval and deployment in regulated industries.
Standards-based. Senior expert-audited. Qualification-driven.
Excel documents risks. QamX qualifies them.
