How to optimize your supplier management
As the medical device and diagnostics industry continues to grow, supplier management is becoming increasingly multifaceted. The ever-mounting effort required…
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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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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Last month (December 2021) the FDA published draft guidance regarding Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.…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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