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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 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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MDCG

New MDCG released

On June 30th, 2023, the Medical Device Coordination Group (MDCG) released Addendum 1 to the position paper MDCG 2022-18 on the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) to legacy devices for which the 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before

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