Last month (December 2021) the FDA published draft guidance regarding Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.…
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This month’s round up covers news from the European Parliament regarding IVDR, a notice for 3rd country IVD manufacturers from…
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This month’s round up covers the latest on Swiss Medtech’s import concerns in relation to Switzerland’s third country status, updated…
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This month’s round up covers a first-of-its-kind publication from the WHO, a collaboration between the FDA, Health Canada and the…
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The FDA has recently published draft guidance regarding the content of premarket submissions for device software functions. The guidance provides…
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This month’s roundup covers MedTech updates from the EU & Switzerland, the latest guidance and resources published by the FDA,…
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Our September MedTech news covers the latest updates and guidance from Europe, the US & Canada, and Asia Pacific. Read…
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Our August MedTech news covers the latest updates, guidance and position papers from the US & Canada, Europe & Switzerland,…
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