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May 26, 2020

2 Years TODAY until the IVDR is mandatory

TICK TOCK! Two years and counting! 26 May 2022, the world will be a very different regulatory landscape for IVD industry, there are now just 2 years before the IVDR is mandatory for any IVD that does not have a Notified Body approval today.
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May 25, 2020

How PMCF surveys can help collect clinical evidence remotely during the COVID-19 pandemic

Due to the COVID-19 pandemic many clinical investigations other than those aimed at management of the disease have been postponed or suspended. 
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May 22, 2020

FAQ Friday: Answers to your questions about China submission

We know there are a lot of questions regarding new regulations. Therefore, we are excited to introduce our new service: FAQ Friday. This week Stephanie Huang answers questions about China submission.
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May 21, 2020

Interview with Diana Nogueira, Senior Consultant Clinical Affairs

We would like to get you all acquainted with our Clinical Affairs Expert. An interview where we talk about her expertise, how a normal workday in times of corona looks like and which trends she observes in the MedTech-world. Ending the interview with valuable advice for everyone in the MedTech world!
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May 20, 2020

Update of COVID-19 tests including WHO, EU, Switzerland and UK

There are many good sources of useful and reliable information emerging to support the development of tests during the pandemic.  This blog summarises some of these documents and whilst they may not be relevant for the particular country to which you intend to market your device they still contain useful information about current best practice or expectations.
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