Avicenna Alliance: enhanced knowledge, improved decisions, better outcomes
FULL MENU

Notified Bodies (NB) Task Force

Notified Bodies (NB) Task Force

BACK

Notified Bodies (NB) Task Force

Mission: Systematic engagement with NBs to advance in silico trials in Europe

Within the policy development working group of the Avicenna Alliance, the Notified Body (NB) task force aims to engage with NBs to increase acceptance of in silico evidence in Europe, provide NBs with guidance documents and offer them assistance in the review process of digital evidence.

Goals

  • Increase acceptance of digital evidence in Europe and by the NBs.
  • Provide guidance to members submitting digital evidence in Europe.
  • Offer assistance to NBs in their review process of digital evidence by engaging members to act as Subject Matter Expert (SME).

Recent achievements

  • Whitepaper published beginning 2021 mapping the various NBs designated under the EU MDR (Regulation 2017/745) and EU IVDR (Regulation 2017/746) together with the perception of in silico evidence among them
  • Engaging with several NBs as well as The European Association for Medical devices of Notified Bodies (Team-NB) to identify the current status, gaps and challenges in the acceptance of in silico evidence by NBs
  • Ongoing collaboration with standardisation bodies to develop & harmonize guidance documents (e.g. DIN)

Simon Sonntag

Simon Sonntag

Co-chair of the Notified Bodies (NB) Task Force

CEO and Co-Founder, Virtonomy.

READ BIO
Bernard Staumont

Bernard Staumont

Co-chair of the Notified Bodies (NB) Task Force

Project Manager and Senior Scientist, University of Liège

READ BIO

NEWS

News Get Ready for Avicenna Day (AAD) 2024!

Get Ready for Avicenna Day (AAD) 2024!

On September 3rd, 2024, Stuttgart (Germany) will host the Avicenna Day (AAD) 2024.

News Welcome ADSILICO to the Avicenna Alliance!

Welcome ADSILICO to the Avicenna Alliance!

We are delighted to announce that ADSILICO has officially joined the Avicenna Alliance! This partnership marks a significant milestone in our collective mission to advance in silico medicine and foster innovation in healthcare.

News Welcome Bioreme

Welcome Bioreme

We are thrilled to welcome BIOREME (Integrating data-driven BIOphysical models into REspiratory MEdicine), a pioneering collaborative network based in the UK, as Avicenna new Partner!

Sign up for our monthly newsletter!

Sign up for our monthly newsletter!

Fill in the fields you find below

Avicenna Alliance is an initiative of:

Avicenna VPH

© 2018-2024 Avicenna Alliance | powered by We Berry