Tuttlingen – Thanks to funding from the Baden-Württemberg Ministry of Economics, Labor and Tourism, joint projects can be started at the Med Alliance BW, which offer all those involved great added value with a manageable investment. These include the Regulatory Affairs Radar for the EU, Switzerland, USA, Great Britain, Canada, Australia and Brazil as well as the Post-Market Radar for the product group "Punching/drilling instruments for hard tissue". Registration closes on July 12th.
What community projects are you starting?
- Update clinical literature reviews
The collaborative clinical literature reviews are among the most valuable support elements for the industry. Funds are now available to tackle updates and bring the content up to date. It starts with the product group "cutting/separating instruments". As before, there is a joint kick-off event with the commissioned service provider so that the development can be tailored as precisely as possible to the needs of the companies involved. - Post Market Radar
The databases of Pubmed, BfArM, Swissmedic, MHRA, FDA recall, Health Canada and Sara are systematically and proactively searched for entries for the product group "Punching/drilling instruments for hard tissue". The participating companies receive the list of reports and can incorporate the relevant information into the post-market documentation or determine any need for corrective or preventive measures to be taken immediately.
Term: 1 year. - Regulatory Affairs Radar
ISO 13485:2016 obliges medical device manufacturers to monitor, evaluate and respond to changes in regulatory requirements in an appropriate manner. In cooperation with a service provider, the companies involved receive regular reports on regulatory changes in the EU, Switzerland, USA, Great Britain, Canada, Australia and Brazil for one year. The report contains, among other things, information about the effects on products and processes as well as corresponding recommendations for action.
Term: 1 year.
What are the requirements?
One requirement is to be a manufacturer of medical devices. Consulting firms or service providers cannot be considered. Another that the company is enrolled with Med Alliance BW. A total of EUR 600.00 - EUR 300.00 per calendar year - is estimated for the years 2023 and 2024. A corresponding agreement will be concluded with MedicalMountains GmbH and can be downloaded from this link.
