medicaldeviceslegal

Medical devices legal and regulatory blog

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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

    • € 500 per data subject in immaterial damages - a quantification of why #GDPR matters #dataprotection #cybersecurity… twitter.com/i/web/status/1… 3 weeks 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… 1 month ago
    • 'Person responsible for regulatory compliance" #PRRC guidance under EU #MDR and #IVDR published #medicaldevices… twitter.com/i/web/status/1… 1 month ago
    • Bottleneck of bottlenecks for #notifiedbody capacity under EU #medicaldevices law #mdr #ivdr medicaldeviceslegal.com/2019/06/13/bot… https://t.co/McscK8wqPU 2 months ago
    • National MDR and IVDR implementation news - Netherlands implementation decree consultation #MDR #IVDR #nationallaw… twitter.com/i/web/status/1… 3 months ago
    • IVDR, in-house developed tests and the state of MDR/IVDR implementation medicaldeviceslegal.com/2019/05/12/ivd… https://t.co/E4x5ZJGzYf 3 months ago
    • This was not the Corrigendum you were looking for, more #MDCG guidance on #scrutiny and national #Brexit exemption… twitter.com/i/web/status/1… 4 months ago
    • What to expect for 2019 with EU #MDR and #IVDR implementation? #medicaldevices #ivds #medtech #invitrodiagnostics… twitter.com/i/web/status/1… 5 months ago
    • Don't give me #Brexit problems, give me Brexit scenarios #medicaldevices #IVDs #medtech #CEcertificates #CEmarking… twitter.com/i/web/status/1… 5 months ago
    • First notified body for EU MDR designated! #MDR #IVDR #medtech #medicaldevices medicaldeviceslegal.com/2019/01/21/fir… https://t.co/X46AeuHftM 6 months ago

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