Cybersecurity considerations for Connected Medical Devices
Medical devices are becoming increasingly connected to the internet, hospital networks, and to other medical devices. Whilst this increased connectivity…
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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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How the early introduction of a QMS will benefit your start-up
The inception of a MedTech start-up stems from someone having a great idea for a new product that improves therapy…
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Consultant Spotlight – Dr Amanda Hirsch-Hüsler
Dr Amanda Hirsch-Hüsler is one of our valued Consultants in Operations. In her Consultant Spotlight below, she talks to us…
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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Last month (December 2021) the FDA published draft guidance regarding Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.…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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