Marta Carnielli

#Riskmanagement for medical devices according to ISO 14971:2019 – Management responsibility and risk policy As part of the general requirements for the #riskmanagementsystem, chapter 4.2 of 144971:2019 describes the ‘Responsibilities of management’. In the original English text of the standard, the term ‘top management’ is used for ‘management’, which should be easier to understand, although it is also vague. Who exactly is the ‘top management’ in a company? Read more about this in our tech blog from seleon GmbH

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Are you prepared for the upcoming EU Medical Device Regulation (MDR) transition deadline on May 26th, 2024? #Compliance is not just important; it's legally mandated. But worry not - PBC Biomed are here to help! By May 26th 2024, all manufacturers *must* have applied for #MDR certification with an MDR notified body or, before their current Medical Device Directive (MDD) certificate expires. Otherwise, the device will no longer qualify as a 'legacy device' under the extension and subsequently cannot be placed on the market. Additionally, a signed contract with an MDR notified body will need to be in place before 26th September 2024. Unsure if your devices qualify for the extension? Contact our team today at [email protected] for more information on how we can support you meet MDR transition timelines. #regulatory #EUMDR #MDD #pbcbiomed #acceleratingmedicalinnovation

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Join Maddalena Pinsi, Senior Regulatory Lead & Associate Head of Medical Devices at BSI, as she walks you through our “Steps towards MDR transition” video series, reminding you of the necessary steps you need to take to access MDR extended transition deadlines. Stay tuned for the next episode and visit our MDR dedicated webpage: https://bit.ly/4bkUPTy #BSI #MedicalDevices #StepsTowardsMDRTransition #Episode2

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Join Maddalena Pinsi, Senior Regulatory Lead & Associate Head of Medical Devices at BSI, as she walks you through our “Steps towards MDR transition” video series, reminding you of the necessary steps you need to take to access MDR extended transition deadlines. Stay tuned for the next episode and visit our MDR dedicated webpage: https://bit.ly/3ZtwY1j #BSI #MedicalDevices #StepsTowardsMDRTransition #Episode2

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2 Kommentare

+ + + MDR/IVDR NEWS + + + Regulatory Consulting companies may NOT consult notified bodies in EU/EAA / Benannte Stellen dürfen nicht beraten werden unter MDR/IVDR. Referenz: MDR und IVDR Annex VII (1.2) Unabhängigkeit und Unparteilichkeit (!) Independence and impartiality (!) is required by law (!) --> Consultancies and notified bodies are held accountable to meet MDR and IVDR. It is now very strict. --> A CMS is also required by consultancies and notified bodies. :) #IVDR #MDR #BeannteStelle #QMS #ISO13485 #ISO14971 #CE #IVD #Medizinprodukte #MedicalDevice #Consultancies #NorifiedBody

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