Innovation meetings are held by major EU Member States Competent Authorities (CA) to help organizations that are developing innovative medical devices (or using novel manufacturing processes) navigate the regulatory processes so they can progress their technologies.
CAs may be consulted via these non-binding meetings on topics such as product qualification/classification, non-clinical testing and clinical evaluations etc. A strategic preparation before engaging CAs in this consultation process is highly advisable to prevent unproductive/negative outcomes for developers.
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