03. August 2023
Effectum’s Plug & Play (e)QMS Bootcamp
Are you a medical device start-up and the topic of quality management system (QMS) gives you more stress than pleasure?
Do you associate with QMS a lot of work that is not really part of your core competence but a necessary evil of your venture?
Then this workshop is just right for you. In our modular and hybrid bootcamp, you will acquire an ISO 13485 QMS, which continuously maintained and can be adapted to your needs.
Curious? Then contact us for more information and save your early bird ticket before August, 15th.
2023-Plug-Play-Bootcamp-Effectum-Medical-2.pdf (0 downloads)
28. February 2023
GREAT TEAM SPIRIT
We believe the secret to enjoy work is also to have fun and laugh as a team. Some of statements we liked most in 2022!
28. February 2023
welcome to the team
Markus Tanner is our new Senior Quality Manager and he joined us in January. Markus brings more than 14 years’ experience from mainly Complaint Handling, Vigilance Reporting, CAPA, HHE, Field Action, Audits, Risk Management and Quality Management Systems (CFR 21 part 820, ISO13485, ISO14971 and MDR).
Markus who is Swiss, lives with his family close to the beautiful Lake Constance. He enjoys family time, sports (skiing & jogging) and reading. Markus is a keen fisherman, but he has realized that instead of improving, the output keeps getting worse by each year.
It’s great to have you on board!
14. February 2023
Welcome to the team!
Uwe joined us in December as Senior Medical Device Expert. He got a very quick deep dive into our projects from the very beginning. Uwe who studies biomedical engineering has been working in the medical device and pharma industry for the last 15 years in different functions developing an expertise in combination products and medical devices.
The new job with Effectum coincided with a move to Switzerland. He describes himself as a very active person who likes to take on new activities both in private sporting activities and as professional at work.
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.