Jun 1, 2022
FDA
The new article provides the details regarding certain specific aspects associated with the quality system information to be provided by the medical device manufacturer applying for marketing approval. Table of Contents The Food and...
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Apr 28, 2022
FDA
The new article addresses the aspects related to the manufacturing information the authority expects to be included in the submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
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Apr 22, 2022
FDA
The new article describes in detail the content of the submission in terms of quality system information and also highlights the aspects related to the design control information. Table of Contents The Food and Drug Administration...
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Apr 19, 2022
FDA
The article provides an overview of the regulatory framework related to the quality system information and highlights the most important aspects associated thereto. Table of Contents The Food and Drug Administration (FDA or the...
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Aug 13, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to ultrasound diagnostic systems and transducers. The present article covers aspects related to the labeling of such products and also...
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