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July 24, 2019

Our 6th office officialy opened in the UK!

Qserve is happy to announce that as of the 1st of July we have opened an office in the UK. The new location is a great addition to our growing global footprint. With rapid business growth and the addition of Sue Spencer (see press release), it is a logical step to start a legal entity and office in one of the main medical device markets in the EU. 

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July 22, 2019

The research naïve study site – always a problem?

Your potential investigator / KOL is very enthusiastic to do your study but does not have an experienced research team, or no study team at all. But he is the only one who has sufficient product usage to conduct a retrospective PMCF study. What do you do?
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July 17, 2019

How to incorporate Article 88 into Post Market Surveillance

 If a manufacturer detects an increase in reports related to expected side effects that might lead to death or a serious deterioration of patient health, this might signal a deterioration in the performance of the device or an off-label use of the device. While many manufacturers may not be in the habit submitting a trend report to the National Competent Authority (NCA) for non-serious incidents, it is required by Article 88 of the Medical Device Regulation (MDR) 2017/745
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July 15, 2019

Approaching 2020, where do we stand?

As we are ready to start the summer holiday in EU, I want to take the opportunity in this blog to look ahead at the impacts of 2020 and what we need to prepare ourselves for. The MedTech sector awaits another year full of challenges and adjustment, especially considering the dynamic regulatory environment in Europe. But also, global developments will potentially reshape the way businesses in the MedTech sector need to deal with expectations, processes and requirements in the quality, regulatory and clinical space.

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July 08, 2019

How helpful is the new EU guidance at this stage?

This month already we saw 3 new guidance documents being published on the EU Commission website, and they are massively distributed in social networks. And two more are expected on very short notice. But how helpful is this additional guidance in times where manufacturers should be finalizing their applications under the EU-MDR? Let’s have a look and reflect…

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