In Vitro Diagnostics and Medical Devices

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CE Marking – Quality Systems – Risk Management
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E-Labeling / eIFU

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Breaking: Qarad Joins the QbD group!

We are proud to announce that Qarad is now a part of the QbD Group. Joining forces with Quality by Design is a big new step in our own 21-year history. By combining forces within the QbD group, we will be able to assist clients in the full ‘from idea to patient’ life cycle even better.

Another wave of MDCG Guidance documents released!

New guidance documents were released by the Medical Device Coordination Group (MDCG). These new documents provide explanatory notes on the IVDR codes, introduce four forms to be used by conformity assessment bodies when applying for designation under the MDR or IVDR, provide guidance on the integration of UDI within an organisation’s QMS, provide instructions for generating CIV-ID for MDR Clinical Investigations and provide guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices.

First MDR and IVDR harmonised standards published

COMMISSION IMPLEMENTING DECISION (EU) 2021/1182 and COMMISSION IMPLEMENTING DECISION (EU) 2021/1195 were published in the Official Journal of the European Union (OJEU).

Leading the market with specialist eIFU services

Qarad’s president and principal consultant, Dirk Stynen, explains how the company has become a market leader in the area of eIFU, and provides insights into how it continues to grow and excel.

Donation to Doctors without Borders!
AZG

Qarad recently did a survey to gain more insight in the eIFU awareness that exists in the field. Thanks to the numerous respondents who answered our survey, Qarad is proud to have donated €2.225 to Doctors Without Borders!

New MDCG Guidance documents released!

The new guidances contain information on status of the Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices, implant cards, EMDN and a Q&A on obligations and related rules for the registration in EUDAMED of certain IVDR/MDR actors.

ISO 15223-1: 2021 Published!

This new standard includes newly validated symbols and defined terms from older guidance documents.

What do Notified Bodies expect of your eIFU solution and its implementation?

Implementing an eIFU solution in your company has major implications on your QMS. Notified Bodies will review how you handled the process. This article explainswhat you can expect.

Regulatory focus: Impact of the latest rules for European IVD device manufacturers

Dirk Stynen, Qarad's founder and President, was interviewed about the impact of the new IVDR on the field.

Medica - November 15-18, 2021
Medica

Visit our booth at Medica 2021 or schedule a meeting upfront with one of our experts! You can find us in Düsseldorf between November 15 and 18, 2021.

QARAD BV

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ISO 13485 and ISO 27001

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