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The European Union's Artificial Intelligence Act is one of the first laws worldwide aiming to curb the risks of AI. Its goal is to protect consumers and ensure that technologies are safe, transparent, and respect fundamental rights. While large corporations already find the compliance path challenging, start‑ups and SMEs (small and medium‑sized enterprises) often feel they are facing a mountain. To help them, experts have designed a framework based on the spiral software development life‑cycle (SDLC) model. In practice, each development stage – from requirements analysis to design, testing, and release – is linked to a specific provision of Regulation (EU) 2024/1689. This means that while the team builds the algorithm, they already check if it meets transparency criteria, if the data are properly anonymized, and if a compliance dossier is ready. The dual benefit is lower costs from late‑stage revisions and avoidance of hefty fines that can reach up to 6 % of turnover. Moreover, the framework promotes internal training, boosting staff expertise and spurring innovation. In short, SMEs no longer need to fear the AI Act; they can use it as a compass to create more responsible and competitive AI products in the European market.

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The proposed framework relies on the Spiral Software Development Life Cycle (Spiral SDLC) model, which blends incremental iterations with continuous risk assessments. In each cycle, the team defines compliance objectives, identifies relevant regulatory requirements (e.g., Article 5 on transparency, Article 9 on high‑risk systems) and maps these requirements to development activities. The requirements analysis phase includes creating a data register, focusing on provenance, quality, and anonymization, in line with Regulation (EU) 2024/1689 provisions concerning personal data processing. During design, "privacy by design" and "security by design" techniques are applied, integrating bias mitigation and algorithm robustness testing. The implementation phase mandates the generation of technical documentation as required by Article 13, containing detailed descriptions of architecture, training data, validation methods, and post‑deployment monitoring plans. Conformance testing encompasses reliability assessments, explainability (XAI) checks, and failure scenario simulations. Finally, release is accompanied by a post‑market monitoring plan that gathers user feedback, analyzes incidents, and periodically updates the model to maintain compliance over time. This iterative approach not only lowers adaptation costs but also cultivates an AI responsibility culture within SMEs, encouraging ethical governance practices and the ability to swiftly respond to future regulatory changes.

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Authors:
Sotirios Stampernas
Date Published:
Original Article www.mdpi.com
Fact-check verified on 07/02/2026
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Creative Commons License CC BY-NC-SA 4.0

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