Evnia is a pioneer in the design and management of PMCF Registries for medical devices for the support of their lifecycle management with a focus on the collection of PMCF data.
Our streamlined solution enables the use of data from PMCF Registries to
📍substantiate claims
📍 frame the intended medical field of a medical device
📍 identify and understand off-label uses
📍 update/optimise device design
📍provide input for new product development
Our strengths?
📍 Holistic approach and critical gap assessment for the identification and weighing of clinical data gaps
📍 In-house multidisciplinary expertise
📍 Standardised processes and templates
📍 Pan-european clinical network with access to diverse populations and the ability to collect both prospective and retrospective clinical data
Find out more about our PMCF Registries Service by going through the dedicated brochure
If you are looking to fulfil your post-market surveillance obligations and monitor the real-world use of your portfolio, let our team of experts accommodate your quality and regulatory journey!
