MDSS Consulting GmbH consists of a qualified team with various educational backgrounds (e.g. medical engineering, biology). Our employees have extensive expertise in the field of medical devices.
We support manufacturers, Authorized Representatives and other economic operators in regards to the requirements of standards which apply to them.
We support you all the way from delimiting your product against other product types, through classifications of medical devices / IVDs, to clinical evaluations. Our daily challenges include creation of technical documentations and various tasks in the quality management area – up to support with regulatory questions concerning development, manufacturing and placing on the market of medical devices worldwide.
Furthermore, our service includes carrying out internal audits and training, as well as support with external audits and authority inspections.
MDSS Consulting GmbH offers both precise emergency assistance and long term consulting projects.