Stories

Digitalization of Technical Documentation

The evolution of the European regulatory framework for medical devices is establishing a progressive transition toward natively digital healthcare information management models. Within this context, the entry into force of Implementing Regulation (UE) 2025/1234, which supplements and amends the provisions of the previous Regulation (UE) 2021/2226, marks a structural shift for the entire MedTech sector.

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Technician working in a server room with a laptop, cables, and data centre racks with blue indicator lights.

The four-eyes principle: a foundation for trust and technical integrity

At Kiwa Medical, the four eyes principle is more than a procedural requirement—it is a daily safeguard for technical quality and regulatory confidence. Whether applied to peer reviews of audit reports, technical documentation assessments, or certification decisions, involving a second qualified reviewer before finalization adds real and measurable value.