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...
Leer másRainer Rothe, Scientific and Regulatory Affairs Officer at Asphalion, attended the online session “Improving Human Health Through Artificial Intelligence” organised by CataloniaBio & HealthTech in...
Leer másDespués 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...
Leer másThe 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...
Leer másOur last webinar is available on Asphalion’s YouTube Channel.
Leer másThis 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...
Leer másAsphalion 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:
Leer másThe Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR) giving manufacturers of Class I devices upclassi...
Leer másThe European Medicines Agency (EMA) has recently revised the Question and Answer (Q&A) document that provides practical considerations concerning the implementation of the medical devices (MDR) and th...
Leer másOn 6th June 2019 COCIR (European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry), the European trade association representing the medical imaging, radiotherapy, ...
Leer másThe European Medicines Agency (EMA) released a draft guideline on the quality requirements for medical devices (MD) in human medicines that include a MD (known as drug device combinations or DDC) for ...
Leer másLa sesión del 5 de mayo, que se centrará en la validación y el prototipado de estos productos, tendrá lugar en el Parc de Recerca UAB
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