MDR | Guidance documents and updates on clinical investigation and evaluation

by Asphalion

4 years ago
medical devices, MDR, guidance

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...

Craash Barcelona | Regulatory Aspects for Medical Devices by Dominique Monferrer

by Asphalion

4 years ago
Biocat, Medical Devices, Dominique Monferrer, Craash Barcelona

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...

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

by Asphalion

4 years ago
cybersecurity, medical devices, Artificial Intelligence, healthcare, drugs, software

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

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

by Tecno-med Ingenieros

4 years ago
medical devices, MDR, reglamentos, IVDR

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...

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

by Asphalion

4 years ago
regulation, EU, medical devices, notified bodies

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...

WEBINAR | MDR postponed: an opportunity that cannot be missed

by Asphalion

4 years ago
medical devices, MDR, opportunity

Our last webinar is available on Asphalion’s YouTube Channel.

Medical Devices | Guidance documents on clinical investigation and evaluation

by Asphalion

4 years ago
MD Software, guidance documents, medical devices

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...

Asphalion is offering all its expertise in Regulatory Affairs

by Asphalion

4 years ago
research, expertise, covid-19, medical devices

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:

MDR corrigendum | Manufacturers of Class I MD may have 4 years more to meet the regulation’s standards

by Asphalion

4 years ago
medical devices, regularions, CEU

The 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...

Q&A document on the implementation of the MDR and IVDR

by Asphalion

4 years ago
legislations, medical devices, European Medicines Agency

The 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...

MDR – Less than one year to go

by Asphalion

5 years ago
medical devices, electromedical industries, health ICT, radiotherapy, medical imaging

On 6th June 2019 COCIR (European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry), the European trade association representing the medical imaging, radiotherapy, ...

Drug Device Combinations: Consultation on draft guideline on quality requirements

by Asphalion

5 years ago
EMA, MD, medical devices, Drug Device

The 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) f...