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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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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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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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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Is my software SaMD?
As health care advances, software has become integrated widely into digital ecosystems that serve both medical and non-medical purposes. Our…
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MedTech news round up April 2021
Our April MedTech news covers a round up of the latest updates and information from the EU Commission, MDCG, FDA,…
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MedTech news round up March 2021
Our MedTech news for March 2021 covers MDR updates from Europe & the UK, an insightful piece on leveraging real-world evidence in regulatory…
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MedTech news round up February 2021
Our MedTech news for February 2021 covers the EU Commission’s new information on the management of legacy devices and IVDs,…
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