Lisa Madison

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The European Union officially released the In Vitro Diagnostic Regulation (IVDR) in 2017, replacing the previous In Vitro Diagnostic Directive (IVDD). The IVDR came into effect in May 2022, but the European Parliament approved a proposal in April 2024 to extend the transition period, with the longest extension possible until 2029. https://www.proregulations.com..../eu-in-vitro-diagnos

EU In Vitro Diagnostic Regulation (IVDR) Registration - Proregulations

Proregulations provides comprehensive EU IVD regulation compliance services to ensure that your products comply with the latest regulatory requirements and obtain the CE mark.

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22 часы работы - Перевести

510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc. https://www.proregulations.com..../u-s-medical-device-