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GMP News

Notified Body Survey on Certificates & Applications under the Medical Devices/IVD Regulation

The results of a survey of 39 Notified Bodies were published by the EU Commission at the end of 2023. It concerns certifications and applications under the Medical Device/IVD Regulations (MDR/IVDR). What are the results?

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Statistical Methods are also important for Medical Devices

Statistics are also necessary in the field of medical devices. In the USA, there is even a separate paragraph in the FDA's Quality System Regulations (QSR, 21 CFR 820). In 21 CFR 820.250, statistical techniques are also required with regard to sampling plans. A current Warning Letter clearly shows this.

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FDA Draft Guidance on Human Factor Studies

The U.S. Food and Drug Administration (FDA) has released a draft guidance document that provides comprehensive guidance on conducting use-related risk analyses (URRAs) for drugs, biological products, and combination products.

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