medicaldeviceslegal

• About Erik Vollebregt
• EU Medical Devices Links

Tag browsing: quality system

• 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

  • Welcome to 2020 - year of the proof of the MDR pudding #medicaldevices #MDR #medtech medicaldeviceslegal.com/2020/01/13/wel… https://t.co/lLMM4h8CMt 5 days ago
  • A not so happy #MDR and #IVDR Christmas Carol #medtech #eumdr #medicaldevices medicaldeviceslegal.com/2019/12/25/a-n… https://t.co/GNyRDJ5TcF 3 weeks ago
  • More on the #PRRC under new EU #medicaldevices regulations #MDR #IVDR medicaldeviceslegal.com/2019/12/12/mor… 1 month ago
  • The Commission and the Council on the #MDR state of affairs #medicaldevices #medtech #eumdr medicaldeviceslegal.com/2019/12/10/the… https://t.co/coF7fV5s3Y 1 month ago
  • #Corrigendum 2 to the EU #MDR and the (potential) consequences for class I #medicaldevices #medtech… twitter.com/i/web/status/1… 1 month ago
  • #Eudamed delayed, but #MDR not delayed - now what? #medicaldevices #medtech #IVDR medicaldeviceslegal.com/2019/11/19/eud… https://t.co/kZQblUstOU 1 month 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… 2 months ago
  • New sort of applicable economic operators regulation for medical devices in the EU: the Market Surveillance Regulat… twitter.com/i/web/status/1… 5 months ago
  • € 500 per data subject in immaterial damages - a quantification of why #GDPR matters #dataprotection #cybersecurity… twitter.com/i/web/status/1… 5 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… 6 months ago

• Most used tags on this blog

  3D printing advertising apps authorised representative borderline Brexit BSi business compliance CE marking Clinical evaluation Clinical investigation clinical trials COCIR competition law conferences Council Cybersecurity Dalli data protection DIA Euromeeting e-labeling eHealth EN 14155 enforcement ENVI Eucomed Eudamed FCPA FDA GDPR genetic testing GHTF HCP hospitals in vitro diagnostics ivd IVDR ivds labeling Liese M&A market surveillance MDD MDR MEDDEV medicinal products mhealth mobile medical apps notified bodies notified body patents personal data PMA PMS post marketing surveillance product liability quality system Recast reprocessing revision Roth-Behrendt scrutiny Security seminar software standalone software standards subcontractors telemedicine transition plan transparency trilogue UDI Unannounced audits vigilance

• Recent comments

  	Erik Vollebregt on Welcome to 2020 – year o…
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• Most used categories on this blog

  Accessories Advertising Borderline Brexit Business compliance CE marking Clinical evaluation Clinical investigation Data Protection e-commerce eHealth Eudamed FCPA In Vitro Diagnostics IVDR Labeling M&A MDR mHealth Notified Body Personal data Placing on the market PMS Product liability Quality system Recast Software Standards Uncategorized Vigilance

• Archives

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