medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
  • EU Medical Devices Links

Tag browsing: quality system

More on 3D printing (and biofabrication)

3D printing of custom medical devices under future EU law

Outlines of the medical devices Recast become more fixed with Council conclusions

Mind the reminder for Medical Devices and M&A seminar

M&A seminar: EU legal & regulatory aspects

Regulatory considerations typically overlooked in medical devices M&A transactions

  • 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

    • Ceci n'est pas une période de transition and first reaction to the #ImplantFiles - #mdr #ivdr #medicaldevices… twitter.com/i/web/status/1… 1 week ago
    • #MDR / #IVDR Implementation: the transition period for the EU medical devices regulations at the halfway point semi… twitter.com/i/web/status/1… 2 months ago
    • Bottlenecks, #Brexit and stalling CAMD roll-out - a new post on #MDR and #IVDR implementation #medicaldevices… twitter.com/i/web/status/1… 4 months ago
    • #IVDR and #MDR implementation seminar on 18 May at @axonlawyers #medicaldevices #ivds medicaldeviceslegal.com/2018/04/12/ivd… https://t.co/3q4PQNRr2d 8 months ago
    • #MDR & #IVDR update after the first MDCG/stakeholders meeting and an IVD seminar at Axon Lawyers #medicaldevices… twitter.com/i/web/status/9… 8 months ago
    • An EU Court #medicaldevices #software qualification case with a twist #samd #mdr #MEDDEV medicaldeviceslegal.com/2018/01/12/an-… 11 months ago
    • Happy New Year - with the EU #MDR transition period going past halfway point #medicaldevices medicaldeviceslegal.com/2018/01/08/hap… https://t.co/PaXZpKHZza 11 months ago
    • RT @IVDAust: @MedDevLegal Australian IVD Companies may also be affected by this... 1 year ago
    • The notified body bottleneck in implementing EU #MDR and #IVDR becoming a problem for #medicaldevices manufacturers medtech.pharmaintelligence.informa.com/MT121869/Exper… 1 year ago
    • RT @mr_mag_online: Advocaten @MedDevLegal @axonlawyers @twobirdsNL @HoyngRokh blij met komst medicijnautoriteit EMA naar Amsterdam https:/… 1 year ago

  • Most used tags on this blog

    3D printing advertising apps authorised representative borderline Brexit business compliance CE mark 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

    Ed Ball on Ceci n’est pas une pério…
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  • Most used categories on this blog

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

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