Archive



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 (243 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…)



29. September 2020

Workshop: Introduction to product developement and regulatory affairs

 

Do you want to understand how product development and regulatory affairs (MDR/IVDR) need to work together to successfully bring products to market?

If the answer is a ‘yes’, this workshop by Nila-Pia Rähle is for you. The course will provide participants with an overview of the regulatory landscape for medical devices in Europe (MDR/IVDR) and will also touch upon different aspects for the US market. Participants will get a good understanding of the product development process, as well as the requirements regarding technical documentation.

Register now – space is limited! (more…)



24. September 2020

Workshop: Bringing your project to success while mastering the challenges of IVDR (in-vitro diagnostics)

The goal of this workshop is to give an overview of the regulatory landscape for in- vitro diagnostics medical devices in Europe (IVDR), the product development process, as well as the requirements regarding technical documentation. Within the IVDR the workshop will focus on the development of medical devices and software.


(more…)



24. June 2018

Partner of Swiss Diagnostics Start-Up Day 2018

The 2nd Swiss Diagnostics Start-up Day took place on June 21, 2018 in Olten (Switzerland). Effectum Medical was one of its key partners. During the event our CEO Karina Candrian presented Effectum Medical and its offering.

The main focus of the event again was the Swissbiolabs Challenge. Congratulations to the winner of the Award 2018, Peter Ruff (Cardioexplorer), runner-up Dr. Prajwal (Clemedi) and 3rd place Sasa Cukovic (Scoliomedis) for their innovative business ideas in the field of diagnostics! See more here.