Qserve's Highlights

Qserve's Highlights

Hot topics from the month of July

Each day our Qserve experts share in-depth content on our website and LinkedIn page. These posts are most popular with our readers. If you want to receive this update in your mailbox, click here and stay up to date!

 

Qserve's July Highlights

July 29, 2020

Why Overall Accuracy Isn't Sufficient? 

There are many changes impacting the IVD world at present, changes to regulation such as the impending implementation of the IVD Regulation in Europe and also new disease states such as SARS-Cov-2 that have been impacting all our lives. 
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July 29, 2020

The new ISO14155 standard for Good Clinical Practice is now published!

After many delays it now officially available: the new ISO14155 standard for clinical investigations of medical devices for human subjects — Good clinical practice . This third edition of the standard cancels and replaces the second edition from 2011. 
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July 14, 2020

Mind the Gap! The 3 Biggest Gaps Faced When Implementing IVDR

If you have traveled on the London Underground you may have noticed the “Mind the Gap” warnings on many platforms. These could also be wise words for the in vitro diagnostic (IVD) industry and should also be pasted on the message board of the European Union’s In Vitro Device Regulation (IVDR) transition teams.
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July 10, 2020

EU publishes sector specific guidance on EU-UK relation change end of the year. What’s relevant for devices?!

The European has adopted yesterday a Communication to help national authorities, businesses and citizens prepare for the inevitable changes that will arise at the end of the transition period of the EU and UK in the Brexit separation process. Changes will occur to cross-border exchanges between the EU and the UK as of 1 January 2021– irrespective of whether an agreement on a future partnership has been concluded or not.
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