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EU-Swiss MRA latest: How MDR & lack of MRA update affect medical devices trade

02/06/2021

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?

20/05/2021

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

03/03/2021

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

21/01/2021

In October last year, the FDA published draft guidance regarding the biocompatibility of certain devices that contact intact skin.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?

08/12/2020

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

26/11/2020

The responsible implementation of Artificial Intelligence within MedTech will transform the efficiency of the industry. But which areas within medical…

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EU-Swiss MRA latest: How MDR & lack of MRA update affect medical devices trade

Is my software SaMD?

MDSAP – When to join the program

5 learnings from FDA’s new Biocompatibility guidance

Ethics, Expectations & Education: What lies ahead for AI in medical devices?

The impact of Artificial Intelligence on the medical device industry

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Topical Article

EU-Swiss MRA latest: How MDR & lack of MRA update affect medical devices trade

Is my software SaMD?

MDSAP – When to join the program

5 learnings from FDA’s new Biocompatibility guidance

Ethics, Expectations & Education: What lies ahead for AI in medical devices?

The impact of Artificial Intelligence on the medical device industry

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