medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
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Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 2

Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 1

  • Erik Vollebregt

    Erik is a founding partner of the boutique life sciences law firm Axon Lawyers and specialised in EU legal and regulatory issues relating to medical technology

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  • Medicaldeviceslegal tweets

    • The Commission and the Council on the #MDR state of affairs #medicaldevices #medtech #eumdr medicaldeviceslegal.com/2019/12/10/the… https://t.co/coF7fV5s3Y 16 hours ago
    • #Corrigendum 2 to the EU #MDR and the (potential) consequences for class I #medicaldevices #medtech… twitter.com/i/web/status/1… 2 days ago
    • #Eudamed delayed, but #MDR not delayed - now what? #medicaldevices #medtech #IVDR medicaldeviceslegal.com/2019/11/19/eud… https://t.co/kZQblUstOU 6 days ago
    • Counting down to the #MDR date of application, and the legal stuff to get right before end May 2020 #medicaldevices… twitter.com/i/web/status/1… 1 month ago
    • New sort of applicable economic operators regulation for medical devices in the EU: the Market Surveillance Regulat… twitter.com/i/web/status/1… 3 months ago
    • € 500 per data subject in immaterial damages - a quantification of why #GDPR matters #dataprotection #cybersecurity… twitter.com/i/web/status/1… 4 months ago
    • Qserve / Axon EU #MDR and #IVDR pop-up conference in Boston MA on 18 July #medicaldevices #invitrodiagnostics #IVDs… twitter.com/i/web/status/1… 5 months ago
    • 'Person responsible for regulatory compliance" #PRRC guidance under EU #MDR and #IVDR published #medicaldevices… twitter.com/i/web/status/1… 5 months ago
    • Bottleneck of bottlenecks for #notifiedbody capacity under EU #medicaldevices law #mdr #ivdr medicaldeviceslegal.com/2019/06/13/bot… https://t.co/McscK8wqPU 6 months ago
    • National MDR and IVDR implementation news - Netherlands implementation decree consultation #MDR #IVDR #nationallaw… twitter.com/i/web/status/1… 7 months ago

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