Archive



20. June 2022

A warm welcome to Camilla

We are strengthening our IVD and software know-how. And let’s see if Camilla can motivate us to act as a triathlon team once as well.

Since completing her MSc in Infection Biology in 2016, Camilla has worked in various Quality Management roles relating to ISO 13485:2016 and IVDR always with increasing responsibilities and has already led a 5-person team. Camilla generally enjoys training and coaching and has given two seminars on Post-Market Surveillance for IVD at the FHNW Muttenz. In the past, Camilla has collaborated on various digitalization projects which will be a great asset for us. (more…)



02. May 2022

Interview for BioLago

In an interview for BioLago – the health network, our co-founder and CEO Karina Candrian talks about the typical challenges startups are facing when trying to bring a new medical device to market.

Karina for example highlights the importance to think about market access and regulatory issues early on. Ideally as soon as you have a suitable product solution. The intended use and properties of a product determine its classification, which in turn has a significant impact on the approval process, budget and time to market.

Read the interview with Karina (in German) on the BioLago blog.



29. November 2021

Effectum Medical & Medicalboard meets the slovenian business delegation

We are always happy to exchange ideas with opinion leaders from other countries, especially with countries that are extremely dynamic and have a high level of innovation.

Here are our 3 key take-aways in terms of regulatory environment: (more…)



08. November 2021

Interview with Nila-Pia Rähle

The Wirtschaftsförderung Olten has published an interview with Nila-Pia Rähle and introduced Effectum Medical AG to the region of Olten. Thank you very much for the opportunity to bring Effectum Medical closer to Olten.

You can find the whole interview here:

Newsletter Wirtschaftsförderung Region Olten



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 (170 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!

 



15. June 2021

Welcome to the team

Join us in welcoming Sarina Flühler our new Junior Quality Manager!

Sarina is just finishing her Bachelor of Science in Medical Engineering. 👩‍🎓 We wish her a lot of success and are convinced that she will graduate with flying colors.

We are convinced that her calm and thoughtful manner and her fresh knowledge will be a great benefit to our team.

For more information about Sarina please visit her LinkedIn profile.

 



15. June 2021

New Service: Swiss Authorized Representative

 

Foreign Medical Device Manufacturers need a Swiss Authorized Representative to sell their product in Switzerland

What many feared has happened. The Mutual Recognition Agreement (MRA) between the EU and Switzerland has failed. We at Effectum Medical have been preparing for this situation, and are pleased to offer the service of Swiss Authorised Representative for foreign medical technology and in-vitro diagnostics companies.

It is a meaningful complement to the founding team’s vision of facilitating product innovation in medical technology and, in the future, providing continuously  optimal patien care in Switzerland.