Hats off to 2023 RAPS EURO Convergence Organisers!
Fantastic job in bringing those from medical devices, IVDs, and pharma together for 2 days of very interesting jam-packed sessions. Great presentations!
Had the great opportunity to talk to several KOLs: Leo Hofvestadt, Erik Vollbregt, Andreas Stange, Martin Witte, Richard Holborow, Michelle Jump, Sabina Hoekstra-van den Bosch, Michelle Sullivan, and many more.
Great conversation with the regular contributor of the RAPS Open Forum, Richard Vincins.
Very interesting discussions with regards to the status of affairs and how to best move forward: Christiana Hofmann, Robert van Boxtel, … and many others.
To the EU regulators, let us expedite the process for clinically proven technologies!!!
Medical device types consisting of well-known materials which are clinically proven in the literature – also described in textbooks - as being safe and effective should be granted expediated MDR CE certification through regulation.
Right now, we are concentrating too many resources on the proven technologies, and not on innovative devices and technologies for MDR CE marking.
Sustainability? What is the ecological footprint of the MDR CE certified device vs MDD CE certified device? Green Deal with the MDR? Topics which EU regulators should consider as we move forward.
Do you agree with me? If yes, support this post on RAPS and LinkedIn. Thanks.
https://www.linkedin.com/feed/update/urn:li:activity:7063232173637521409/
-> This Post had to be edited due to unwanted "<o:p></o:p>"
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Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
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