MedTech news round up August 2021
Our August MedTech news covers the latest updates, guidance and position papers from the US & Canada, Europe & Switzerland,…
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Congenius welcomes Corinne Larke as new Head of Regulatory
We are delighted to welcome our new Head of Regulatory to the Congenius team. Corinne Larke joins us following over…
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MedTech news round up July 2021
Our July MedTech news covers the latest from the EU commission on harmonised standards under MDR, FDA’s recent efforts to…
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Is a decentralized approach the future for clinical trials?
A decentralized clinical trial (DCT) is a trial where subject recruitment, delivery and administration of study medication and collection of…
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What Biden’s Executive Order means for medical device cybersecurity
This year on May 12, the Biden administration passed an Executive Order on improving cybersecurity in the US, with the…
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Consultant Spotlight – Marc Friedli
Marc Friedli joined us in January 2021 as a Senior Consultant in Operations. Process engineer, production specialist, bass guitarist and…
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How UKCA will impact Swiss medical device approval in Great Britain
The UK’s exit from the European Union brought with it Britain’s withdrawal from the scope of application of the EU…
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MedTech news round up June 2021
Our MedTech news for June 2021 includes an update on the EU-Swiss MRA, the latest guidance documents from the FDA…
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