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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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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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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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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MDSAP – When to join the program
Based on ISO 13485:2016, MDSAP (Medical Device Single Audit Program) is an audit program that allows for a single regulatory…
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5 learnings from FDA’s new Biocompatibility guidance
In October last year, the FDA published draft guidance regarding the biocompatibility of certain devices that contact intact skin. Our…
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Ethics, Expectations & Education: What lies ahead for AI in medical devices?
Artificial Intelligence is changing the world. In a MedTech context, it enables a small team to affect many lives. To…
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The impact of Artificial Intelligence on the medical device industry
The responsible implementation of Artificial Intelligence within MedTech will transform the efficiency of the industry. But which areas within medical…
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