The IVD experts

Consulting

CE Marking | Quality Systems | Risk Management

E-Labeling / eIFU

Improve your efficiency and save more than you would think

Consulting

CE Marking | Quality Systems | Risk Management

E-Labeling / eIFU

Improve your efficiency and save more than you would think

 

Training

Qarad is part of the QbD Group

We are proud to be a member of the QbD Group which supports life science companies worldwide throughout the entire product lifecycle – from idea to patient.

Together, we form a multinational organization with over 450 high-qualified employees offering services in regulatory affairs, clinical, qualification & validation, quality assurance, quality control, software solutions and go to market. Read more

News & Events

New MDCG Guidance documents released! (September 2022)

On August 10th, 2022, the Medical Device Coordination Group (MDCG) released a new guidance document. This document aims to provide guidance to the authorities responsible for notified bodies and joint assessment teams (JATs) when conducting a) assessments of conformity assessment bodies (CABs) that apply for designation of notified bodies (NB)

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New MDCG Guidance documents released (August 2022)

On July 13th 2022, the Medical Device Coordination Group (MDCG) released a new guidance document. This latest release provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. To that end, this guidance intends to describe harmonised administrative practices

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UK Consultation

UK Consultation outcome

Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK). On June 26th 2022, the outcome of this consultation was published. This document describes the transitional arrangements for in vitro diagnostic

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Qarad IVDR Conference 2022

NHOW Brussels

October 11-13

Get the latest IVDR insights during our three-day conference, including a pre-conference workshop.