sitem-insel AG
MDR/IVDR 2020, Implant files and beyond - are you ready?
The symposium "An International Look at Health Care Transformation" will have an international perspective with speakers from Singapore, Cambodia, and Canada referring to health care transformation.
The MDR Support Panel presents and discusses various solutions for the implementation of the MDR concerning Combination Products.
Alle Interessierten sind an diesem Tag herzlich dazu eingeladen, die sitem-insel AG und ihre Plattformen kennenzulernen.
Weitere Informationen folgen in Kürze
The MDR Readiness Day gives the opportunity to discuss specific questions and exchange ideas on the topic of Third Countries Regulation.
MDR/IVDR 2020, Implant files and beyond - are you ready?
sitem-insel organizes together with its partners from University of Bern and from Universität Hamburg the first Open Strategy Paper Development Workshop on October 11, 2019. The keynote will be held by Richard Whittington from Saïd Business School, University of Oxford.
The MDR Support Panel presents and discusses various solutions for the implementation of the MDR concerning Third Countries Regulation.
MDR/IVDR 2020, Implant files and beyond - are you ready?
The MDR Readiness Day gives the opportunity to exchange first experience with the implementation of MDR.
The MDR Support Panel presents and discusses first experience with the impelmentation of MDR.
The MDR Readiness Day gives the opportunity to discuss specific questions and exchange ideas on the topic of EUDAMED & UDI.
The MDR Support Panel presents and discusses various solutions for the implementation of the MDR concerning EUDAMED & UDI.
We have the great pleasure to welcome Bob Neuhard, Executive Director at the University of California San Diego. He has introduced the Open Innovation Platform called Ideawave at UCSD and has now several years of experience with this fantastic tool. On April 5th, he will share his experience with the use of the OI crowdsourcing platform in advancing strategic priorities.
The third Swiss MDR/IVDR Forum will explain for which products you need clinical data and how you can obtain them: What information is required to obtain an adequate clinical evaluation? What requirements do they have to meet?
During the MDR Readiness Day, manufacturers will have the opportunity to exchange ideas, answer open questions themselves and find out important discussion areas for them in the areas of development, technical documentation, registration, and market surveillance. Topics to be analyzed in depth by industry representatives will be dealt with in the subsequent MDR Support Panel.
Reusable low-risk surgical medical devices now belong to the Ir (reusable) class. There is no transitional period for these products, so they must have undergone the new procedure by May 2020. This presents the industry with great challenges.
During the MDR Readiness Day, manufacturers will have the opportunity to exchange ideas, answer open questions themselves and find out important discussion areas for them in the areas of development, technical documentation, registration, and market surveillance. Topics to be analyzed in depth by industry representatives will be dealt with in the subsequent MDR Support Panel.
With the new MDR, the clinical evidence requirements for Class IIb and III products are increasing substantially. Find out how you can generate this evidence efficiently.
The MDR Readiness Day gives the opportunity to discuss specific questions and exchange ideas on the topic of Combination Products.
Was genau bedeutet translationale Medizin und was will damit erreicht werden? Welche Chancen und auch Gefahren bringt diese Herangehensweise mit sich? Welche Prozesse müssen eingehalten werden, damit Forschungsergebnisse im Spital umgesetzt werden können? Was ist die Sitem-Insel und wie wichtig ist sie für den Forschungs- und Wirtschaftsstandort Bern?
Was genau bedeutet translationale Medizin und was will damit erreicht werden? Welche Chancen und auch Gefahren bringt diese Herangehensweise mit sich? Welche Prozesse müssen eingehalten werden, damit Forschungsergebnisse im Spital umgesetzt werden können? Was ist die Sitem-Insel und wie wichtig ist sie für den Forschungs- und Wirtschaftsstandort Bern?
After a successful selection and proof-of-concept phase, we are now very excited to launch the pilot phase of our Open Innovation Platform called idea@sitem.