Are your metrology systems 21 CFR Part 11 compliant?

~ The importance of data integrity in the medical device industry ~

According to the US Food and Drug Administration (FDA), 7,252 medical products were recalled in 2020 — 41 per cent of these products were medical devices. Recalls are costly, both financially and to a business’ reputation, but also can pose a risk to patient safety, something all medical device businesses want to avoid. Here Jason McGlynn, commercial manager for Ireland at industrial metrology specialist The Sempre Group, explains how quality engineers can maintain data integrity — and stay 21 CFR Part 11 compliant — to prevent recalls.

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