medicaldeviceslegal

• About Erik Vollebregt
• EU Medical Devices Links

Tag browsing: quality system

• Erik Vollebregt

  

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• Medicaldeviceslegal tweets

  • Commission working on proposal to postpone #MDR date of application for one year #medicaldevices #medtech #eumdr medicaldeviceslegal.com/?p=6801 6 days ago
  • The #MDCG guidance on significant changes - a significant change? #medicaldevices #eumdr #medtech #MDR #IVDR… twitter.com/i/web/status/1… 1 week ago
  • The #MDR and the #Covid-19 recommendation - a possible template for fixing the MDR and #IVDR bottleneck… twitter.com/i/web/status/1… 1 week ago
  • New #MDCG Class I Article 120 (3) and (4) #MDR guidance - nothing new but nice summary of requirements… twitter.com/i/web/status/1… 2 weeks ago
  • The #MDCG #cybersecurity guidance - a helpful rush job #medicaldevices #ehealth #mhealth #medtech #euMDR #MDR #IVDR… twitter.com/i/web/status/1… 2 weeks ago
  • The #MDCG MDR joint implementation plan for the #MDR (not the #IVDR) #medicaldevices #medtech #eumdr… twitter.com/i/web/status/1… 2 weeks ago
  • #Brexit is a fact - now deal with it And what does that mean for #medicaldevices for the coming years?… twitter.com/i/web/status/1… 2 months ago
  • Welcome to 2020 - year of the proof of the MDR pudding #medicaldevices #MDR #medtech medicaldeviceslegal.com/2020/01/13/wel… https://t.co/lLMM4h8CMt 2 months 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 months ago
  • More on the #PRRC under new EU #medicaldevices regulations #MDR #IVDR medicaldeviceslegal.com/2019/12/12/mor… 3 months ago

• Most used tags on this blog

  3D printing advertising apps authorised representative Blue Guide borderline Brexit BSi business compliance CE marking Clinical evaluation Clinical investigation clinical trials COCIR 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 MDCG 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

  	What is a Significan… on The MDCG guidance on significa…
  	Julie Omohundro on Commission working on proposal…
  	Erik Vollebregt on Commission working on proposal…

• 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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