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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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Evnia is a recognised regulatory and clinical consultancy services provider. At Evnia, our goal is to accelerate innovation in the medical industry in order to change the quality of care and life for patients. We offer full value chain services in Research & Development, Regulatory Compliance, and Management for the Pharmaceutical, Biotechnology and Medical Device companies, as well as manufacturers. Evnia’s cross-functional team of experts includes Medical Writers, Medical Doctors, Biocompatibility Experts, and Engineers for Usability, Risk & Validation. This allows us to ensure a comprehensive assessment of the device’s safety and performance profile and bridge the gap between what notified bodies expect and what you currently have in your regulatory documentation.
Copenhagen Business Center Hellerup Strandvejen 60 DK-2900, Copenhagen Denmark
Dr. Efstathios Vassiliadis CEO Phone: 0045 40 10 77 69 Email: ev@evnia.dk