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The changing landscape for FDA EUAs

16/09/2021

An Emergency Use Authorisation (EUA) allows the FDA to protect the health of the US public against chemical, biological, radiological,…

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Cobalt in medical devices: Do the benefits outweigh the risks?

09/09/2021

In 2017, cobalt was up-classified by the European Chemicals Agency (ECHA) with respect to its carcinogenic, reproductive toxicity and mutagenic…

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Is a decentralized approach the future for clinical trials?

22/07/2021

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

15/07/2021

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

01/07/2021

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

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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Topical Article

The changing landscape for FDA EUAs

Cobalt in medical devices: Do the benefits outweigh the risks?

Is a decentralized approach the future for clinical trials?

What Biden’s Executive Order means for medical device cybersecurity

How UKCA will impact Swiss medical device approval in Great Britain

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

Is my software SaMD?

MDSAP – When to join the program

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Topical Article

The changing landscape for FDA EUAs

Cobalt in medical devices: Do the benefits outweigh the risks?

Is a decentralized approach the future for clinical trials?

What Biden’s Executive Order means for medical device cybersecurity

How UKCA will impact Swiss medical device approval in Great Britain

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

Is my software SaMD?

MDSAP – When to join the program

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