Tuttlingen – As important as the international markets are for German medical technology manufacturers, the path to bringing products onto the market there is sometimes rocky. On March 23rd and 24th, the MedicalMountains GmbH symposium will focus on questions relating to international approvals: with well-founded analyses, pragmatic tips, joint workshops and informative discussions - including with a representative of the FDA who will be traveling extra.
At the symposium, the impulses come from medical technology companies - with their experiences, challenges, but also success stories. The activities of the industry are embedded in an international network of specifications. The most important sales market for German manufacturers is still the USA - so it is all the more gratifying to be able to welcome a representative of the FDA to Tuttlingen. A focus of the contribution will be on the eStar procedure of the US authorities, which can serve as a model for the digitization of approval procedures. The focus is also on efforts to achieve greater international harmonization in approval procedures. One starting point is the "Non-In Vitro Diagnostic Device Market Authorization Table of Contents", nIVD MA ToC for short, of the IMDRF.
As far as the process is concerned, a two-day approach was deliberately chosen. Since the exchange between the participants and with the speakers is always a plus, the dialogue should be given even more space - in this case especially on the first evening with a joint dinner and subsequent get-together.
Further information on the program items that have already been set and the option to register can be found at this link.
