The transition time for In vitro diagnostic medical devices (IVDs) to comply with the EU IVD Regulation 2016/746 (IVDR) is arriving at its end: IVDR will be fully implemented from 26 May 2022. New IVD...
Read moreAs of May 2022, IVDR will become fully applicable, displacing the old In vitro diagnostic directive (IVDD). Implementing IVDR will be much easier with a good action plan in place. Asphalion can aid yo...
Read morel ON 0123 para la IVDR TÜV SÜD Product Service GmbH Zertifizierstellen Ridlerstraße 65 80339 MÜNCHEN Germany ha emitido su primer certificado para un producto de la clase B según IVDR.Esta es la ...
Read moreNext month, Dominique Monferrer will hold a webinar aimed to help manufacturers of in vitro diagnostic medical devices to understand the impact of the new In Vitro Diagnostic Regulation (IVDR), the mo...
Read moreDespués de varios desencuentros… e.g. publicación de EN ISO 14971:2019 y EN ISO 24971:2020 sin anexos Z, el comité CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical d...
Read moreThe European Commission (EC) has published a Commission Implementing Decision requesting a review (standardisation) of a set of existing standards, as well as new standards to be drafted, for support ...
Read moreLes informamos de la apertura de inscripciones para nuestra próxima Formación WEBINAR EN DIRECTO DE 1'5 horas en directo + 8 horas en teleformación del día 26 de mayo de 2020: FORMACIÓN IVDR : 2...
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