Post-market surveillance

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Post-market surveillance & vigilance

Intake every post-market signal, assess reportability, and track the regulatory clock from the date of awareness. Deadlines follow FDA 21 CFR 803, EU MDR Article 87, Health Canada and UK MHRA rules — the earliest applicable deadline is shown.

First-pass advice: likely not reportable. No harm and no malfunction recorded — document the rationale for not reporting.

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