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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.  
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February 22, 2021

QserveTalks: 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. 
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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!
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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.

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February 08, 2021

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

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