Combined medical devices are those that combine a medical device with an active ingredient (drugs and/or biological products). Due to the fact that combined devices involve components that would usually be regulated by different authorities, they require a special approach regarding its development, as well as the strategy to determine its biocompatibility and safety, with the consequent impact in its certification, defined by its primary mode of action (PMOA).
In BioAplicada we can help you to lay out a comprehensive strategy to determine the biocompatibility and safety of your combined device that will allow you to successfully reach certification by the competent authority.
