AURA — a quality-management platform for regulated medical devices

AURA is a compliance platform — quality-management software that helps companies operate their AI systems and medical devices in line with the rules, for example the EU AI Act, ISO 42001, ISO 9001 and ISO 13485.

AURA compliance platform

AURA brings everything into one place: document control, risk assessments, training, audits and conformity evidence. Instead of compliance work scattered across spreadsheets and shared folders, teams get one structured system where every requirement, record and piece of proof has a home.

One platform covers the frameworks that matter for regulated AI and medical software — the EU AI Act, ISO 42001, ISO 9001 and ISO 13485 among others. You start with structured workflows and can add AI-powered automation when you are ready, without duplicated effort or rework.

AURA is aimed above all at small and medium-sized enterprises that serve the EU market and must meet its AI and medical-device requirements. It is the same discipline that keeps SeeCure trustworthy — now made available to others working under the same rules.

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