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SQA Regulatory Surveillance Summary | Monthly Update 2022 – May

SQA

In March 2022, Philips Health Systems informed the MHRA of an important safety issue due to potential unexpected shutdowns of all their V60 and V60 Plus non-invasive ventilators. V60 and V60 Plus devices are designed for in-hospital use. World Health Organization (WHO). This alert should be acted on immediately.

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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

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