medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
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Tag browsing: software

Updates, patches, add-ons, plugins & the Blue Guide

The MHRA’s new guidance on standalone software as medical device and DIA Euromeeting update

IMDRF Software as Medical Device definition document completes

CE certification of standalone software and apps seminar – the movie

Healthcare software enforcement alert

E-labeling in the EU – some practical experience and: Save the apps market!

IMDRF invites comments on standalone software key definitions

FDA’s draft guidance on cybersecurity: nothing exciting but useful examples

Team NB FAQ on EN62304 standard for software lifecycle processes

What’s cooking at IMDRF? UDI and software, among other things

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  • Medicaldeviceslegal tweets

    • Finally remote initial audits under the #MDR and #IVDR, or not (yet)? #medtech #diagnostics #IVDs #medicaldevices medicaldeviceslegal.com/2021/01/24/fin… 1 month ago
    • Outlook for EU #medicaldevices and #IVD regulation for 2021 - and happy new year! #medtech #eumdr #diagnostics… twitter.com/i/web/status/1… 1 month ago
    • The #Brexit ‘deal’ has finally dropped - what’s in it for the #medicaldevices industry? #MDR #IVDR #medtech #eudmr… twitter.com/i/web/status/1… 2 months ago
    • The EU Court's Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required… twitter.com/i/web/status/1… 7 months ago
    • #Standardisation request for #MDR and #IVDR refused - now what? #medicaldevices #medtech #eumdr #diagnostics #IVDs medicaldeviceslegal.com/2020/06/20/sta… 8 months ago
    • The urgency with #IVDs under the EU #IVDR #medicaldevices #medtech #dx #diagnostics #invitrodiagnostics medicaldeviceslegal.com/2020/06/08/the… 8 months ago
    • EU #MDR: where are we at Date of Entry into Force plus three years and a little bit? #medicaldevices #IVDs… twitter.com/i/web/status/1… 8 months ago
    • EU #MDR date of application move: politically a done deal now #medicaldevices #medtech #eumdr… twitter.com/i/web/status/1… 10 months ago
    • New #MDCG guidance on temporary extraordinary measures related to medical device #NotifiedBody #audits during… twitter.com/i/web/status/1… 10 months ago
    • #MDR amendment proposal article 120 (3) oversight set to be fixed #medicaldevices #postponement #medtech #EUMDR… twitter.com/i/web/status/1… 10 months ago
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