Archive



29. August 2022

ISO 13485 Certificate for In-Vitro Diagnostic products received

In spring, we completed our first IVD audit and our ISO 13485 certificate for In-Vitro Diagnostic products has now arrived! This has been the next important step for us to complete our service offering which now covers In-Vitro diagnostics in addition to Medical Device products and software. We are of course pleased to have received the certificate, but we are equally happy to have team members with a proven track record in diagnostics who can expertly accompany our customer projects.



28. July 2022

Swiss Symposium in Point-of-Care Diagnostics October 20th, 2022

This years POCDx Symposium will take place in Basel and Effectum Medical is honored to be a part of it. In addition to the main symposium there will be a pre-event held on October 19th where Effectum Medical will be speaking about IVDR Requirements for Diagnostic Products – in vitro tests, software, instruments

Registration is now open and you can benefit from early bird rates until August 31st, 2022.

For more details about the symposium and to register please visit the symposium website.



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.



14. March 2022

Welcome to the team

We are pleased to announce that Harald Züger has joined the Effectum team. He is taking care of our financials and bringing them to the next level. Harald is a very skilled finance executive with 20+ years of comprehensive international, management and board experience. Since 2010 he has been providing finance and operational support for life science and healthcare start-ups in Switzerland, France and Austria and has worked in set-ups like Effectum before.

For more information about Harald visit his LinkedIn profile.



31. January 2022

5 year anniversary Effectum Medical

5 years ago, on January 16th, 2017 Effectum Medical was officially born. A big thank you to our great customer, partners and team without whom this journey would not be possible!

(more…)



09. December 2021

Effectum Medical joins the KAPSLY service-for-equity platform

Supporting start-ups is in our DNA. Therefore, we are very happy to announce that we have joined the KAPSLY platform! KAPSLY is a service-for-equity platform that connects service providers with promising start-ups.

We are the right partner to validate product concepts through the lens of regulatory requirements. Through our sister company MEDICALBOARD we can also offer Marketing and Strategy expertise and are thereby able to support start-ups throughout their product journey.

For more information about KAPSLY visit their website or get in touch!

 



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