Evnia is a pioneer in the design and conduct of PMCF Surveys and has been supporting the postmarket surveillance and PMCF programs of MedTech manufacturers with sustainable, streamlined solutions that enable the use of data from PMCF Surveys to
๐substantiate claims
๐ frame the intended medical field of a medical device
๐ identify and understand off-label uses
๐ update/optimise device design
๐provide input for new product development
Our strengths?
๐ Holistic approach and critical gap assessment for the identification and weighing of clinical data gaps and the justification of PMCF needs
๐ In-house multidisciplinary expertise
๐ Standardised processes and templates
๐ Pan-european clinical network with access to diverse populations and the ability to collect both prospective and retrospective clinical data
Read more in our dedicated brochure
If you are looking for optimised lifecycle management activities and to maximise your post-approval market status, we have the right program!
Let our team of experts accommodate your quality and regulatory journey!