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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

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, quality control, software solutions and services and go to market. Read more

News & Events

Medtech Clinical Evidence

Medtech clinical evidence requirements under the EU IVDR (Rev 3)

Last month, Medtech released the 3rd revision of the clinical evidence requirements under the EU In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR). This guidance document from Medtech is a collection of questions and answers designed to help manufacturers navigate their performance evaluation obligations under the new IVDR. Medtech – Clinical evidence requirements

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MDCG Guidance documents

New MDCG Guidance documents released (March 2023)

On February 14th, 2023, the Medical Device Coordination Group (MDCG) released a Q&A on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices (MDCG 2023-03). MDCG 2023-03 Q&A on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices. This document

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New position paper from team NB released!

On March 1st, 2023, Team NB released a new position paper on best practice guidance for the submission of technical documentation under Annex II and Annex III of the European (EU) In Vitro Diagnostic Regulation 2017/746 (IVDR). This best practice guidance document has been developed by members of Team NB

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