Whitepaper: Accelerating Qualification of Additive Manufacturing Processes
How the integration of amsight into the Aconity3D platform paves the way to certified serial production in metal 3D printing

What Is This About?

The leap from additive prototyping to qualified serial production often fails at one critical point: the data foundation. Standards such as ISO 13485 (medical devices) and AS9100 (aerospace) demand end-to-end, revision-proof documentation – from powder to finished part.

At the same time, OEMs in the semiconductor, aerospace, and medical device industries are cascading structured process and quality data requirements down to their suppliers through quality assurance agreements (QAAs). Without this foundation, approval for serial delivery is practically no longer possible.

This is exactly where the strategic partnership between Aconity3D and amsight comes in – established in March 2025.

What Will You Learn From the Whitepaper?

Four Integration Pillars for Industrial AM Qualification

The whitepaper describes how integrating amsight into the Aconity3D ecosystem addresses four key challenges of additive serial production:

1. Automated Data Acquisition – Sensor data is automatically imported and analyzed after each build job. Manual documentation, traditionally a major time driver and error source, is largely eliminated.

2. Data-Driven Process Analysis – Statistical evaluation of process and sensor data identifies patterns, trends, and deviations – the basis for stable, reproducible processes.

3. Audit-Ready Reports at the Push of a Button – Quality documentation is generated directly from the linked data foundation, without manual intervention.

4. Open Process Parameters as a Qualification Enabler – Aconity3D’s full parameter access enables independent material and geometry qualification. amsight captures every change in a versioned, comparable format.

Additional Topics Covered in Detail:

• – Digital audit trail at part level – seamless linking of material, parameters, machine status, and quality data in a revision-proof format
• – ISO 13485-compliant Device History Records (DHR) – systematic traceability with defined access rights
• – Process validation following IQ/OQ/PQ frameworks – structured datasets as evidence for certifications
• – Scalability across machines and production sites – standardized data schemas for the transition to full production environments
• – Real-world example: Magnesium LPBF – how parametric openness and traceability unlock new material classes for industrial manufacturing (including the EU project BIOMET4D)

Who Is This Whitepaper For?

This whitepaper is aimed at decision-makers and technical leads in additive manufacturing who are planning the transition to qualified serial production – particularly in regulated industries such as medical devices, aerospace, defense, and semiconductors.

It is especially valuable if you:

• – Want to shorten qualification cycles in the LPBF process
• – Need to build an audit-ready data foundation for ISO 13485 or AS9100 certification
• – Must meet OEM requirements and quality assurance agreements in a structured way
• – Plan to independently qualify new materials or geometries

The Result at a Glance

The combination of Aconity3D’s open machine architecture and amsight’s data-driven process analysis significantly reduces time-to-qualification and provides a clearly structured path to industrial serial production in additive manufacturing.

Download the Full Whitepaper Now

Learn in detail how digital traceability, automated quality documentation, and open process parameters work together – and how you can leverage them in your qualification project.

Whitepaper by Aconity3D and amsight · 4 pages · PDF