MedTech news roundup March 2022
This month’s roundup covers tackling medical device supply shortages in Switzerland, advice on direct procurement of foreign medical devices into…
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MedTech news round up February 2022
This month’s round up covers MDCG guidance regarding IVDs, an update from the EU Commission on the IVDR implementation plan,…
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Using Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
Last month (December 2021) the FDA published draft guidance regarding Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.…
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MedTech news round up January 2022
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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MedTech news round up December 2021
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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MedTech news round up November 2021
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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Preparing your Premarket Submission for Device Software Functions
The FDA has recently published draft guidance regarding the content of premarket submissions for device software functions. The guidance provides…
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MedTech news round up October 2021
This month’s roundup covers MedTech updates from the EU & Switzerland, the latest guidance and resources published by the FDA,…
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