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Klaris

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Klaris is an AI-based review platform for medical-device technical documentation that checks documents clause by clause against regulatory requirements and flags cross-file inconsistencies, citing each gap to the exact clause and offering drafted remediation. It serves regulatory teams in MedTech preparing submissions for EU MDR 2017/745 and FDA biocompatibility (ISO 10993-1:2025).

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Frequently asked questions

What does Klaris do?
Klaris is an AI-based review platform for medical-device technical documentation that checks documents clause by clause against regulatory requirements and flags cross-file inconsistencies, citing each gap to the exact clause and offering drafted remediation. It serves regulatory teams in MedTech preparing submissions for EU MDR 2017/745 and FDA biocompatibility (ISO 10993-1:2025).
Who are Klaris's investors?
Klaris's investors include Antler.