Qarad Logo - Part of the QbD Group

regulatory experts in IVD

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

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 500 high-qualified employees offering services in regulatory affairs, clinical, qualification & validation, quality assurance, quality control, software solutions and services and go to market. Read more

News & Events

MDCG

New MDCG Guidance documents released (January 2023 Update 2)

On January 10th, 2023, the Medical Device Coordination Group (MDCG) released a new guidance on the  health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. This guidance is very important for healthcare professionals and researchers of health institutions aiming to design, manufacture, modify and use

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MDR Transitional Regime

New EC proposal to amend MDR transitional regime

On January 6th, 2023, the European Commission (EC) adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the MDR (Medical Devices Regulation). The new deadlines depend on the

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