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. Oktober 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.
01. Oktober 2019
Claudia Reichle joins Effectum Medical’s team of experts
We are happy to announce that our team of experts keeps on growing. We would like to welcome Claudia Reichle as Project Manager QM & RA who is joining us as of October 1st, 2019. Claudia looks back on more than 20 years of professional experience within the medical device industry as Product Manager and Group Manager. She has recently obtained a degree as Quality Manager Medical Devices.
For more information about Claudia please visit her profile on LinkedIn.
25. September 2019
BioLAGO and Effectum Medical offer start-up support across borders
BioLAGO is the cross-border network for the health industry in the four-country-region of Lake Constance (Germany, Switzerland, Austria and Liechtenstein) and Effectum Medical has joined as a new member.
While BioLAGO links industry with science for innovations, promotes knowledge transfer and the foundation of new firms, Effectum Medical helps start-ups to bring their ideas to market successfully. By joining the network, Effectum Medical is going to expand its international network and find new cooperation and service partners. „We are looking forward to exchanging ideas and experiences with experts in MedTech and IVD“, says Karina Candrian, CEO of Effectum Medical.
We look forward to a successful and close cooperation and are delighted to become part of the BioLAGO community.
To read more, please click here.
21. Mai 2019
Effectum Medical and IREM enter into cooperation
Effectum Medical is proud to announce the start of a new partnership with the UZH IncubatorLab at the Institute for Regenerative Medicine · IREM of the University of Zurich.
In the UZH IncubatorLab, UZH Entrepreneur Fellows in BioTech and MedTech are given the opportunity to further develop their idea, invention, project technology, product or novel service and to evaluate the potential for the commercialization of such a technology, product or service before founding a company. (mehr …)
29. April 2019
Quaregia and Effectum Medical are synergizing by entering into a new partnership
Our customers can take advantage of cost and time savings by gaining immediate access to Effectum Medical’s quality management system as well as support throughout the entire product development process until product launch whilst profiting of QUAREGIA’s profound expert knowledge in Quality Management and Regulatory Affairs Services for Medical Devices, Medical Device Software, In Vitro Diagnostic Devices and Combination Products (www.quaregia.com).
23. April 2019
BioLAGO Academy Workshop: How to successfully master the new EU MDR/IVDR regulations?
Is your company prepared to face the strategic and operational challenges imposed by the new EU MDR/IVDR regulations? BioLAGO academy will give answers to the most important questions regarding the new EU guidelines in a one-day workshop on 8. May 2019 in Allensbach.
The workshop brings together leading experts from the industry to discuss the current situation and possible solutions for the German, Swiss and Austrian market.
If you are in MedTech, you are affected by the MDR/IVDR! Don’t miss this opportunity to prepare your company for the future and address your concerns! To register, please click here. (mehr …)
26. März 2019
Effectum Medical expands Medical Software Competence
Effectum Medical is delighted to have received the extended ISO certification for Medical Software (according to IEC 62304). With the extension of the ISO certification, we are now able to certify stand-alone medical software, as well as medical devices with a software component.
At the same time, we are welcoming Mathias Eng as our new Expert QM & RA, Software. Mathias looks back on more than 17 years of experience as an expert for quality management systems and medical device regulations (mehr …)
01. Februar 2019
Two partners – one goal: Effectum Medical and Runway Incubator offer MedTech Start-ups early phase support
Effectum Medical and the RUNWAY Incubator (managed by the Institute for Innovation and Entrepreneurship of the ZHAW School of Management and Law Winterthur) are teaming up to support MedTech start-ups in Eastern Switzerland especially in the early and seed phase. (mehr …)
01. Februar 2019
Successful event on Diagnostics start-ups and start-up support
In a combined effort to promote innovation in diagnostics, Swissbiolabs and Baselarea.swiss hosted a special event last week focusing on diagnostics start-ups and start-up support, during which our client Resistell gave valuable insights on how to become a successful MedTech start-up.