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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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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MedTech news round up May 2021
Our May MedTech news includes timely updates from the US and EU, links to recent notable documents from the MDCG…
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