Close this search box.
Close this search box.

Are your metrology systems 21 CFR Part 11 compliant?

Written by:

Alison Gardner

~ 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.

Read more

Having trouble measuring difficult characteristics, dealing with quality bottlenecks, or demonstrating compliance?

We’re here to simplify your quality inspection experience.

We’ll give you expert advice on the right precision systems for your application, software to streamline your quality process from drawing to report, plus we’ll support you with sub-contract measurement and calibration services.

Let us solve your measuring challenges.

In this article, we will cover:

Looking to streamline your quality process?

Discover our range ofhigh-precision, cutting edge measurement technologies for demonstrating your quality compliance.

Download our brochure today.

Related Articles

Subscribe to our newsletter and get all the latest news and insights straight to your inbox


Find out how Sempre can solve your measuring challenge.