Clinical investigations with medical devices should be performed by health care professionals with scientific and medical qualifications and appropriate experience, preferably in the proposed research...
Read moreNutraCO2S project demonstrates that it is feasible to recover and transform agro-industrial production waste into new natural materials rich in bioactive molecules, which could be safely used in Food ...
Read moreA new perspective of the future manufacturing process
Read moreI am a medical device professional with R&D and regulatory background and over 10 years’ experience in the field of Medical Devices, combining a technical background with a fulfilling career in the ...
Read moreA Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity assessment is a process by which you demonstrate that the produ...
Read moreProviding guidance about Regulatory Affairs and Trade changes in the Pharma and Medical Devices industries
Read moreNew Medical Devices Software (MDSW) should be developed in Europe in accordance with the requirements of the new legislative framework given by REGULATION (EU) 2017/745 on medical devices (hereinaf...
Read moreAsphalion’s Board of Directors is pleased to announce the appointment of Dominique Monferrer as new Medical Devices Director.
Read moreToday is an exciting day for Asphalion as we have reached 15,000 followers on LinkedIn!
Read moreNow 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...
Read moreEUDAMED 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...
Read moreFrom 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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