FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to design control. The scope of the document covers such aspects as design input and design output. The...
EU MDR/IVDR
The European Medicines Agency (EMA) has published a guidance document dedicated to the quality documentation for medicinal products when used with a medical device. The present document constitutes a final version which will enter into force on January 1, 2022. Table...
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to significant changes to medical devices already placed on the market. The document is intended to assist medical...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, continuously develops and publishes guidance documents dedicated to various medical devices. In these documents, the FDA addresses the most...
FDA
The Food and Drug Administration (FDA or the Agency), the country’s regulating authority in the sphere of healthcare products, has developed detailed guidelines dedicated to labeling requirements for various types of medical devices. The present article supplements...
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