medicaldeviceslegal

• About Erik Vollebregt

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.

  Email Address:

  Sign me up!

  Join 6,991 other followers

• Subscribe via RSS

   RSS - Posts

   RSS - Comments

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

  

• Medicaldeviceslegal tweets

  • MDCG 2022-14, a new position paper by the #MDCG in an attempt to remedy the issues of #notifiedbody capacity.… twitter.com/i/web/status/1… 2 weeks ago
  • More on the #BlueGuide 2022: analysis of the new elements in Chapter 2 and what they mean for #medicaldevices and… twitter.com/i/web/status/1… 1 month ago
  • A first look at the new(ish) things for #medicaldevices and #IVDs in the 2022 #BlueGuide #medtech #MDR #IVDR… twitter.com/i/web/status/1… 1 month ago
  • Managing the 2024 MDR danger zone - and outlines of a potential solution in MDCG 2022-11 #medicaldevices #EUMDR… twitter.com/i/web/status/1… 3 months ago
  • MDCG guidance as pseudo-legislation - a constitutional no-no under the #MDR and #IVDR #medicaldevices… twitter.com/i/web/status/1… 3 months ago
  • Happy #IVDR day! The EU IVDR is now applicable - and what does that mean? #moleculardiagnostics #medicaldevices… twitter.com/i/web/status/1… 4 months ago
  • More on the interpretation of the concept of placing on the market #EUMDR #EUIVDR #medicaldevices #CEmarking… twitter.com/i/web/status/1… 7 months ago
  • Some critical remarks on inconsistencies and new requirements in MDCG 2021-27 guidance Q&A on importers and distrib… twitter.com/i/web/status/1… 9 months ago
  • #IVDR amendment proposal moving on up to adoption with Council not touching the Commission's proposed text… twitter.com/i/web/status/1… 10 months ago
  • Commission makes legislative proposal to manage #IVDR transition #diagnostics #IVDs #invitrodiagnostics #medtech… twitter.com/i/web/status/1… 11 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 GHTF guidance HCP 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 placing on the market PMA PMS post marketing surveillance product liability quality system Recast reprocessing revision Roth-Behrendt scrutiny seminar software standards subcontractors Swixit telemedicine transition plan transparency Turkxit UDI Unannounced audits vigilance

• Recent comments

  	Olga van Grol-Lawlor on Verelendung is a process,…
  	Paul Kosters on Verelendung is a process,…
  	Michael Maier on Verelendung is a process,…

• 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 August 2022  (3) June 2022  (2) May 2022  (1) February 2022  (1) December 2021  (2) October 2021  (1) May 2021  (3) April 2021  (1) 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)