medicaldeviceslegal

• About Erik Vollebregt
• EU Medical Devices Links

Tag browsing: quality system

• Erik Vollebregt

  

• Email Subscription

  Enter your email address to subscribe to this blog and receive notifications of new posts by email.

  Join 6,378 other followers

  Email Address:

  Sign me up!

• Subscribe via RSS

   RSS - Posts

   RSS - Comments

• All content on this blog is subject to a Creative Commons Licence

  

• 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… 2 months 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

• 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 Date of Application 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

  	Uitgelicht en gespot… on Finally remote initial audits,…
  	ahmednabil1956 on Finally remote initial audits,…
  	Paul Kosters on Finally remote initial audits,…

• 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

  Archives Select Month January 2021  (1) December 2020  (2) July 2020  (1) June 2020  (3) April 2020  (4) March 2020  (5) January 2020  (2) December 2019  (4) November 2019  (1) October 2019  (1) August 2019  (1) July 2019  (2) June 2019  (1) May 2019  (2) March 2019  (2) February 2019  (1) January 2019  (2) December 2018  (1) October 2018  (1) August 2018  (1) April 2018  (1) March 2018  (1) January 2018  (2) November 2017  (3) October 2017  (1) September 2017  (3) August 2017  (1) July 2017  (1) June 2017  (1) May 2017  (2) April 2017  (2) March 2017  (1) February 2017  (2) January 2017  (1) December 2016  (3) October 2016  (1) July 2016  (1) June 2016  (4) May 2016  (3) April 2016  (1) March 2016  (1) February 2016  (1) December 2015  (1) November 2015  (3) October 2015  (1) June 2015  (5) April 2015  (2) February 2015  (1) January 2015  (3) December 2014  (1) November 2014  (3) October 2014  (3) September 2014  (3) August 2014  (1) July 2014  (2) June 2014  (1) May 2014  (1) April 2014  (4) March 2014  (4) February 2014  (1) January 2014  (5) December 2013  (3) November 2013  (3) October 2013  (5) September 2013  (5) August 2013  (4) July 2013  (4) June 2013  (3) May 2013  (4) April 2013  (8) March 2013  (5) February 2013  (4) January 2013  (1) December 2012  (2) November 2012  (2) October 2012  (2) September 2012  (4) August 2012  (1) July 2012  (1) June 2012  (2) May 2012  (1) April 2012  (3) March 2012  (4) February 2012  (3) January 2012  (3) December 2011  (2) November 2011  (1) October 2011  (5) September 2011  (3) August 2011  (2) July 2011  (3) June 2011  (4) May 2011  (4) April 2011  (6) March 2011  (5) February 2011  (4) January 2011  (6) December 2010  (7) November 2010  (9)