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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How to determine legitimate FDA approval
Within the medical devices field, you may have come across terms like “FDA registered”, “FDA certified” and “FDA Registration Certificate”.…
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EU-Swiss MRA latest: How MDR & lack of MRA update affect medical devices trade
Until now, Switzerland and the EU have relied on a specific chapter of the Mutual Recognition Agreement (MRA) for trade…
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