Qserve's Highlights of February

Qserve's Highlights

Hot topics from the month of February

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 February highlights:

February 23, 2021

Staying Ahead of the IVDR Tsunami

All stakeholders in the IVD regulatory sector have seen a steep change in IVDR transition activity since the start of 2021 as the reality hits manufacturers that there is less than 18 months to the date of application.  
February 22, 2021

Podcast: MDR Deadline Countdown | Episode 001: What we learned from the MDR so far

Welcome to our first series: MDR Deadline Countdown,  where we want to guide you as much as possible in your journey towards the MDR. Our host Gert Bos will invite new guest-speakers every episode and discuss topics regarding the MDR. During our very first episode, we will give you an overview of what we learned so far from the MDR. 
February 16, 2021

Interview with Stephanie Huang, NMPA & Clinical study Expert 

We would like to get you all acquainted with our NMPA and Clinical study expert, Stephanie Huang. An interview where we talk about her expertise, how a normal workday looks like and which trends she observes in the MedTech-world. Ending the interview with valuable advice for everyone in the MedTech world!
February 10, 2021

MDR Article 16 MDR certificates for Importers and Distributors who translate IFU/labeling or rebox medical devices

Did you know that as an importer or distributor who translates labeling or reboxes (non-sterile) medical devices that (a) it is mandated you have a QMS and (b) you need to have an “MDR Art. 16 certificate” for such activities (which is NOT an ISO 13485/9001 certificate or a CE certificate)? Let's recap.

February 08, 2021

On-Demand Webinar: Using PMCF surveys as a valid clinical data collection tool


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