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

Common specifications

Common Specifications adopted!

On July 4th, 2022, the European Commission adopted “Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council”. This implementing regulation lays down common specifications

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Blue Guide

Blue Guide 2022 published!

On June 29th, 2022, the European Commission published an updated version of the Blue Guide on the implementation of EU product rules. The Blue Guide is a non-binding instrument first published in 2000. It has been subsequently updated twice, in 2014 and 2016. The 2022 revision is a substantial update and

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EURL Implementing Regulations

EURL Implementing Regulations released!

On June 17th, 2022, the European Commission adopted two implementing regulations that outline the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices (Commission Implementing Regulation (EU) 2022/944) as well as the fees that may be levied by EU reference laboratories

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Companion diagnostics

EMA Guidance Companion Diagnostics!

On June 17th, 2022, the European Medicines Agency (EMA) released its guidance on procedural aspects to facilitate the consultation procedure to the EMA by notified bodies on companion diagnostics, as per Article 48(3), (4), (7) and (8) of the IVDR. This guidance document is intended to provide the relevant parties, in

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