Archive



30. September 2021

FDA database for AI/ML-enabled medical devices

Artificial intelligence (AI), and specifically machine learning (ML), has become an important part of an increasing number of medical devices. Due to the increased interest in these medical devices, the FDA has basis a publicly available information created a list of AI/ML-enabled medical devices currently being marketed in the US.

The list is not an exhaustive or comprehensive resource of AI/ML-enabled medical devices but gives an overview of what is currently available.

Link FDA list



30. September 2021

In a row with M&A specialists and MedTech country leads 


We feel honoured that Verve Ventures has interviewed Karina to receive insights about market access and regulatory. Read the full interview here 



21. September 2021

Paving the way for innovative medical devices – overcoming regulatory hurdles for development in academia

 

Not only a great contribution by DKF (Department of Clinical Research, University of Basel) and DBE (Department of Biomedical Engineering | University of Basel), but above all a pragmatic way how to succeed in the university sector

  •   – to quickly make innovative developments available to research
  •   – to keep the well-being of patients in mind.

 

We are honored to have been selected as a partner and to be able to assist with our quality management system and regulatory affairs expertise.

These are projects that fit Effectum Medical’s DNA – bringing medical device innovations to market efficiently and cost-effectively. Many thanks  to Prof. Philippe Claude Cattin, Robin Sandkühler, Roland John, Christiane Pauli-Magnus, Dr. Unfer-Grauwiler Sandra for the great collaboration!

We are looking forward to the first market approvals and wish the team continued success!

For all interested parties, here is the access to the whole article, page 12-16
DKForum_Ausgabe17_Online-2.pdf (161 downloads)

 



02. September 2021

Why do we need a Swiss Authorized Representative (Swiss AR)?

Health Tech Cluster Switzerland’s event “Why do we need a Swiss Authorized Representative (Swiss AR)?” last week showed that interest remains high.

Our three Key Take Aways:

  • The swissmedic sheet clearly lays out the two fundamental levels: Physical product responsibility – manufacturer, importer, distributor; Formal and safety concerns – CH REP.
  • The role of the importer is significantly enhanced in the logistics chain, as he ensures that only products that comply with the MepV are placed on the market.
  • Contrary to all expectations, swissmedic does not specify the location of the “Person Responsible for Regulatory Compliance”. The decisive factor is that he or she is able to exercise the responsibility in accordance with the legal requirements

Many thanks again to Stefan Leuthold for inviting Ulrike Neuberger. It was a pleasure to organize the event together with Beni Hirt and Michael Maier!

If you have any further questions, please feel free to contact us!