Regcompl.AI GmbH digitalizes and automates the certification process for medical devices and software as a medical device. Its offering includes modular capabilities such as automated feasibility checks, AI-driven gap analyses, an intelligent co‑pilot for project participants, and automated drafting of the EU Declaration of Conformity, with alignment to MDR and applicable standards (e.g. ISO 13485, ISO 14971, IEC 62304).
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Industry:Software Development
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Certification of Medical Devices and Software as a Medical Device
Digitalisation and automation of the certification process for medical devices and Software as a Medical Device with AI, including Feasibility Check, Gap analysis, Co-Pilot and final documentation.
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