Date: 6th and 7th of March 2020
Costs: Regular € 1750.- (including lunch & drinks)
There is an enormous amount of work required to transition from the IVDD to the IVDR, manufacturers need to recognize that the IVDR is more complex and detailed and will, therefore, require more recourses to maintain as well as implement.
Preparing technical files
What are the requirements
What data do you need and what sources can you use
Creating files that are easy to review
Understanding Clinical Evidence requirements for existing devices
Scientific validity, Analytical Performance, Clinical Performance
PEP and PERs
More detailed information about the training will follow soon.