Navigating Clinical Evaluation for SaMD
Clinical evaluation is an ongoing process that’s conducted throughout the life cycle of a medical device. It is a structured,…
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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Last month (December 2021) the FDA published draft guidance regarding Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.…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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Clinical Evaluation under MDR: 5 tips for producing compliant CERs
Following a four-year transition period, MDR finally became fully applicable on 26 May 2021. Since this date, clinical evaluations for…
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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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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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