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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

Join our IVDR & MDR Conference 2023

The learning event for IVD & MD experts. Get valuable insights and guidance documents. Stay ahead of industry trends.

Proud to be 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, lab services, software solutions and services and business & communications. Read more

News & Events

New MDCG Guidance documents released

On November 29th, 2023, the Medical Device Coordination Group (MDCG) released the first revision on the position paper on the notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements. (MDCG 2022-11 Revision 1). This position paper calls for the continued full commitment of all

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New Study supporting the monitoring of availability of medical devices on the EU market – Surveys for MD and IVD manufacturers and authorised representatives

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) – via its European Health and Digital Executive Agency (HaDEA) – commissioned a “Study supporting the monitoring of the availability of medical devices on the EU market”. New Study supporting the monitoring of availability of medical devices on the

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New MDCG released!

On September 26th, 2023, the Medical Device Coordination Group (MDCG) released a Q&A on the transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR. The newly published Q&A document intends to facilitate the application of the transitional provisions set out in Commission Implementing

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