Archive
18. June 2020
We are a DayOne Accelerator partner!
Innovation in digital health offers a huge opportunity to create true value by improving patient care and clinical outcomes. This, especially in telemedicine, diagnostics, and prevention or early detection. Sharing common missions with the DayOne Accelerator, we are happy to be their partner and support the start-ups of the DayOne Accelerator programm, increase their chances for success and accelerate their time-to market.
DayOne, initiated by a Core Team of volunteering industry experts, medical doctors, tech enthusiasts and researchers, serves a growing community of 2000 healthcare innovators throughout the Basel life sciences and healthcare ecosystem. DayOne is operated by BaselArea.swiss, the office for promoting innovation and inward investment for the cantons of Basel-Stadt, Basel-Landschaft and Jura. DayOne is supported with a special financial contribution by the canton of Basel-Stadt and also by a wide range of knowledge partners and supporting partners.
For more information about Dayone click here
25. May 2020
Postponement of MDR – opportunities, pitfalls and impact on timelines
Now you have the opportunity for MDD submissions, the door has reopened for a moment. This might facilitate your market access. Please find below some answers to the most important questions regarding timelines.
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16. May 2020
JOIN OUR TEAM! WE ARE HIRING
Effectum Medical is a young company that is breaking new ground in the areas of quality management and regulatory affairs in the medical device industry. Our vision is to facilitate and accelerate medical device product innovation by offering an affordable, outsourced quality management system (QMS) and legal manufacturing. Our customers are start-ups, as well as global medical device manufacturers.
To further grow our company, we are looking for a
Project Manager Regulatory Affairs (60-100%)
to join our team.
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31. March 2020
EU AUTHORISED REPRESENTATIVE – WE ARE READY
If the MDR will be implemented in May this year, it is very likely, that the MRA (Mutual Recognition Agreement) between Switzerland and Europe will not be signed before that date. Therefore, Swiss Med-Tech Companies will need an authorised representative in the EU. Effectum Medical is prepared and can ensure its customers seamless access to the European market.
26. March 2020
MONIKA TRÜMPLER-MÜLLER JOINS EFFECTUM MEDICAL TEAM
We are happy to announce that our team keeps on growing. We would like to welcome Monika Trümpler who has joined us as of March 19th as Marketing & Management Support . Monika looks back to more than 20 years of experience in marketing and administration. We’re glad to welcome her to our team and to count on her support on our marketing and administrative tasks. For more information about Monika please visit her profile on LinkedIn.
24. January 2020
Wir suchen Verstärkung für unser Team
Bist Du interessiert in einem jungen dynamischen Team die Firma aktiv mitzugestalten? Dann suchen wir vielleicht genau Dich!
MitarbeiterIn Administration 40%
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18. December 2019
Woman in Digital Health – Event
Wednesday, January 8th, 18:30-21:00 in Zürich
Woman in Digital Health – Event
“WiDh presents: Karina Candrian (Medtech Entrepreneur)”
Click here for more information
16. December 2019
Congratulations to Nila and Karina!
Innosuisse Coaches Nila-Pia Rähle and Karina Candrian
Congratulations to our new Innosuisse-Coaches Nila-Pia Rähle (COO at Effectum Medical) and Karina Candrian (CEO at Effectum Medical).
Please click here for more information on the start-up coaching from Innosuisse.
06. November 2019
Put it simply – the new UDI-System
A straightforward overview with a practical example
Download our white paper
The white paper provides a straightforward illustration and description of the UDI System, based on a practical example.
The new EU-Regulation for medical devices (MDR) requires a unique product identification and the adherence to registration regulation.
The UDI code shall be publicly available through registration in a central database. The requirement for UDI is new and the central database is not yet available. Therefore, no practical examples and experiences are available. However, medical device manufacturers must find a way to prepare for the implementation of the UDI system.
07. October 2019
New Effectum Medical Workshop, 19. November 2019 (Olten)
Bringing your project to success while mastering the challenges of MDR/IVDR, 19. November, 2019 (Olten)
Which steps do I have to take for development and industrialization of my product? How do I document appropriately and how can I ensure to get certification? These are the ultimate questions for anyone developing a new product. If these are the challenges you are facing, this workshop session will help you to master them.
The objective of our new workshop is to understand the product development process for medical devices as well as the regulatory requirements regarding documentation. You will get an overview of the product development process and documentation, combined with hands-on experience from real case examples.
If you are manager or team member in a start-up or spin-off, this workshop is for you! For more information on this complimentary workshop and how to register, please click here.
