Additive Manufacturing Qualification for Regulated Sectors: Systematic Review of Accepted Evidence

Authors

  • Alen Bilic-Ras Centre for Additive Manufacturing, Lonjsko Centre for Emerging Materials, Sisak, Croatia Author
  • Dympna Lyng Department of Standards, Ox Mountains Institute of Advanced Technology, Ballina, Ireland Author
  • Fanni-Sofia Lampela Department of Metrology, Keski-Pohjanmaa Institute of Advanced Technology, Kokkola, Finland Author

DOI:

https://doi.org/10.5281/zenodo.22674614

Keywords:

Additive Manufacturing Qualification for Regulated Sectors; Next-generation R&D; Evidence synthesis; Reproducibility; Research methodology

Abstract

There is real interest in additive manufacturing qualification for regulated sectors right now, and real uncertainty about exactly
where it delivers the most value. We pull together the current evidence for additive manufacturing qualification for regulated
sectors, covering the methodological, practical, regulatory and cost angles, with an eye on where practice has genuinely settled
and where engineers and reviewers are still largely working it out for themselves. Selective, context-specific adoption looks better
supported by the evidence gathered here than either broad rollout or blanket avoidance

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Published

2026-09-04

Issue

Vol. 5 No. 2 (2026): vol 5 issue 2 2026

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