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Highlights

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.

Auditing MDR 2017/745 Notified Body Podcast Post Market Clinical Follow-up Highlights

January 31, 2020

EU-MDR and EU-IVDR Booklets for sale in two convenient sizes

The Qserve MDR and IVDR in two convenient sizes: one for on your desk and one for in your bag.

Europe Medical Device Regulations IVDR Qserve Group

Results

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.

In-Vitro Diagnostics IVDR Quality Assurance Regulatory Affairs Highlights

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.

Auditing MDR 2017/745 Notified Body Podcast Post Market Clinical Follow-up Highlights

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!

China Interview NMPA Regulatory Affairs Highlights

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.

Labelling Medical Device Regulations Highlights

February 08, 2021

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

Clinical Data PMCF Surveys Webinar Highlights

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