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Conformo AI | EU MDR, ISO 13485 Compliance Reviews & Product Details

Conformo is an AI-assisted review platform for Notified Bodies assessing medical device technical documentation under EU MDR, IVDR and ISO 13485. It checks technical files against applicable requirements and flags missing or partial evidence with source references. Reviewers can search documentation in natural language and get inconsistencies highlighted. It also drafts non-conformities traceable to requirement clauses, along with assessment reports, and reviewers approve or edit every output.

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