Tuttlingen – The working groups are at work, the first new joint projects are starting: The Med Alliance BW initiated by MedicalMountains GmbH is advancing medical technology manufacturers from the entire German-speaking region with practical and practice-oriented solutions. For example, with a regulatory affairs radar that will be activated soon.
"By companies, for companies": Since the beginning of the year, the Med Alliance BW has been supporting the medical technology industry with its proven guiding principle and new concept. The door, emphasizes MedicalMountains Managing Director Julia Steckeler, “is still open. Anyone who wants to take part is very welcome.” Get in and benefit; with a commitment that each Med Alliance company can shape according to its individual goals and resources. An added value that should not be underestimated results from the involvement in working groups. “The exchange at eye level, between the experts, provides very valuable insights and knowledge. Especially when working on a common issue, on a common goal.” This includes various publications, such as a “Project Plan TD” for leaner implementation of the MDR requirements, an information and position paper on PFAS restrictions or “Explanatory Notes” on the new MDR transitional provisions, addressed to authorities and dealers in non-EU countries. A comprehensive publication on biocompatibility will follow in the summer. Documents that will ultimately be made available without distinction to all companies that have registered in 2023 and 2024 for a total of 600 euros.
At the same time, new joint projects can be initiated thanks to funding from the Baden-Württemberg Ministry of Economics, Labor and Tourism. An additional contribution of 300 euros is charged in each case, but "the consideration more than makes up for this amount," Julia Steckeler is convinced. For example with the regulatory affairs radar, which will be activated shortly. This is used to scan the regulatory requirements in the EU, Switzerland, USA, Great Britain, Canada, Australia and Brazil for a year. The reports contain information about the changes and tips on what to consider when implementing them. “It is tedious work to collect this important information on your own. Since the observed target markets are relevant for most manufacturers, a joint approach makes sense,” says Julia Steckeler. "Together" means: A service provider is commissioned with the execution; The fixed contributions of the participating Med Alliance companies contribute to its financing.
A joint post-market radar will subsequently be launched with a similar principle. The databases of Pubmed, BfArM, Swissmedic, MHRA, FDA recall, Health Canada and Sara are systematically and proactively searched for entries for a selected product group. "The companies involved receive the list of reports and can transfer the information relevant to them to the post-market documentation," explains the MedicalMountains Managing Director. “In this way, small and medium-sized companies can save a great deal of effort and gain the certainty that no entry will be overlooked.” The term is also one year.
The first clinical literature evaluations that have already been prepared jointly are also to be professionally updated as part of the project funding. It starts with the update for cutting/separating instruments.
- Are you interested in relief? Further information on the participation in the Med Alliance BW and the working groups is available at https://www.med-alliance.de. Details on the planned joint projects can be obtained directly from Julia Steckeler (steckeler@medicalmountains.de) or Meinrad Kempf (kempf@medicalmountains.de).
