We don’t only write clinical evaluations, SOTAs and PMCF plans, we also help to develop the processes around these subjects to fit your organization.
A situation we regularly encounter in our day-to-day business is that the clinical evaluation does not get the focus it needs early in the development process of our customers. Many of the problems we help to solve late in project timelines can be anticipated in a very early stage and consequently easy circumvented. We assist you to fit the clinical evaluation in your product development process and build the link to risk management. Consequently, inputs and outputs from and to PMS and PMCF are taken into account as well.
