Archive
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 (306 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.
20. April 2021
THANK YOU
It is never too late to say THANK YOU!
Despite the pandemic situation we were able to over-achieve our goals in 2020.
Many thanks to all our customers who have contributed to our success story so far. We feel honoured about the trust you have placed in us and we are delighted to support and accompany the journey of your innovation!
Thanks a lot, to our highly motivated and committed team, which managed onboarding and integration of new members successfully, also in remote modus and delivered outstanding results to our customers. Grateful for and proud about your contribution!
Let’s continue the ride of our common journey – to bring innovation to market
Yours sincerely
Karina Candrian & Nila-Pia Rähle
29. March 2021
Johann made it to our new office!
Taking into account the Corona requirements, Johann was the first,
allowed to move into the new office of
Effectum Medical at Kirchgasse 11, 4600 Olten.
Isn’t that a wonderful and safe place for him?
We hope that our team can join him physically soon. We are also looking forward to welcoming our customers in the nice office space.
Even if most of things are virtually possible – it does not replace the personal interchange!
See you soon and stay healthy
Your Effectum Medical Team
25. March 2021
IVDR report reveals pain points IVD companies are currently facing
We are delighted to present the results of our market survey “IVDR-Readiness-Survey-Report-March” which was conducted end of 2020 together with our partner Expand Healthcare.
IVDR-Readiness-Survey-Report-March-2021-1.pdf (338 downloads )
The aim was to
- gain insights where companies stand with regards to IVDR implementation
- understand which threats and challenges they are facing
- how IVDR challenges can be solved
Effectum Medical’s passion is TO BE CLOSE TO YOUR INNOVATION AND bring it to market.
23. February 2021
From Uganda to Effectum Medical!
Please join us in welcoming Markus Stohler to the team as our new Head of Supply Chain Operations.
Markus has a background in Mechanical Engineering and a Master’s in Medical Technology and we are looking forward to benefiting from his international experience in Supply Chain Management, Manufacturing Technologies, Process Validation and Risk Management.
For more information about Markus please visit his LinkedIn profile.
25. November 2020
Upcoming event of our partner BioLAGO
We are delighted that Karina Candrian is invited to speak at the upcoming event of our partner BioLAGO: Der Countdown läuft: IVDR, MDR, und Vigilanz jetzt richtig umsetzen.
If you did not register yet for Dec. 4, but you would like to stay up to date about MDR/IVDR and change knowledge with like-minded, then the event is right for you.
Read more about the program
06. October 2020
Are you well prepared for the new IVDR?
The new IVDR, coming into force on May 2022, will have major implications on your operations. The need of a notified body for app. 80% of products, even for existing ones, and the assignment of a Person Responsible for Regulatory Compliance (PRRC) are only some of them. (more…)
