Asphalion celebrates 15,000 followers on LinkedIn!

por Asphalion

Today is an exciting day for Asphalion as we have reached 15,000 followers on LinkedIn!

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Updates on the Ongoing guidance development within MDCG Subgroups

por Asphalion

Now that the year is about to come to an end, the European Commission has updated the information on the MDCG’s work in progress, indicating the planning for the endorsement of the guidance document...

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Nueva sección de la web de la Comision para la puesta en marcha 1/12/2020 del modulo de registro de actores de EUDAMED

por Tecno-med Ingenieros

EUDAMED es 22 de mayo de 2022 la Comisión Europea ha confirmado su interés en hacer disponibles los 6 módulos gradualmente, y ha anunciado la apertura del modulo de registro de actores incluyendo e...

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Brexit | New guidance documents from MHRA

por Asphalion

From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.

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MDR | Guidance documents and updates on clinical investigation and evaluation

por Asphalion

Although the date of application of the Medical Devices Regulation (MDR) has been postponed, on 26 May 2021 the Regulation will become fully applicable, following the transition period. As​ previous...

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Craash Barcelona | Regulatory Aspects for Medical Devices by Dominique Monferrer

por Asphalion

Dominique Monferrer, Asphalion’s Medical Devices Expert, was invited to give a talk on Regulatory Aspects for Medical Devices to participants of the 3rd edition of Craash Barcelona program organized...

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Asphalion attended the online session 'Improving Human Health Through Artificial Intelligence'

por Asphalion

Rainer Rothe, Scientific and Regulatory Affairs Officer at Asphalion, attended the online session “Improving Human Health Through Artificial Intelligence” organised by CataloniaBio & HealthTech in...

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Rechazado el nuevo mandato de normalización para las normas armonizadas con MDR e IVDR

por Tecno-med Ingenieros

Después 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...

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New regulation to ease the renewal of the designation of NBs and prevent shortages of MDs in the EU

por Asphalion

The European Commission (EC) has published a Commission Implementing Regulation to ease the renewal of the designation of notified bodies (NBs) and prevent shortages of medical devices (MDs) in the Eu...

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WEBINAR | MDR postponed: an opportunity that cannot be missed

por Asphalion

Our last webinar is available on Asphalion’s YouTube Ch​annel.

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Medical Devices | Guidance documents on clinical investigation and evaluation

por Asphalion

This week brings some good news for the medical devices (MD) manufacturers and notified bodies, as 4 ​different guidance documents on topics related to clinical investigation and evaluation have bee...

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Asphalion is offering all its expertise in Regulatory Affairs

por Asphalion

Asphalion and its experts are committed to bring solutions and alternatives to society during this exceptional situation. That is why we are offering all our expertise in Regulatory Affairs by:

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