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EisnerSafety

  1. Do you know how to use EN62304 (med dvc s/w life-cycle) as implemented under the EU MDD &AIMDD? ht.ly/bajpb about 23 hours ago via HootSuite
  2. AAMI News Feed Added to Eisner Safety Consultants website ht.ly/aRAQ0 9:27 PM May 11th via HootSuite
  3. Article added 'Update on National Implementations of IEC60601-1:2005' May 2012 in Journal of Medical Device Regulations ht.ly/aAccq 9:22 PM Apr 28th via HootSuite
  4. EU medical device (MEDDEVs) guidance documents newly released & updated ht.ly/ar2tV 5:30 AM Apr 23rd via HootSuite
  5. EU Commission Regulation of Electronic IFUs of Medical Devices (MDD & AIMDD but not IVDD) ht.ly/9ZDNs 6:00 AM Apr 2nd via HootSuite
  6. Health Canada’s Guidance – Transition from IEC 60601-1 2nd to 3rd edition & related IEC 60601 Series of Standards ht.ly/9PvBE 9:38 PM Mar 22nd via HootSuite
  7. NB-MED 60601-1 issues team releases Ver. 1.1 FAQ on Implementation of EN60601-1:2006 with respect to the MDD 93/42/EEC ht.ly/8UTCK 1:07 AM Feb 7th via HootSuite
  8. EC Press Release 2 Feb '12 asks for further scientific study & draws 1st lessons from recent fraud on breast implants ht.ly/8RwHE 11:15 AM Feb 3rd via HootSuite
  9. UK MHRA Revamped Website! ht.ly/8NCNY 10:10 PM Jan 31st via HootSuite
  10. 1 Step Closer to EU Medical Device e-Labeling ht.ly/8NCEX 10:04 PM Jan 31st via HootSuite
  11. 16 June '12 Update on DRAFT NB-MED EN60601 3rd ed. Implementation for EU ht.ly/8NCuV 9:58 PM Jan 31st via HootSuite
  12. FDA Innovation Pathway – Technology that Addresses Unmet Medical Needs ht.ly/8xmQn 11:28 PM Jan 17th via HootSuite
  13. Top 10 Medical Cities Now & in the Future ht.ly/82GAk 11:31 AM Dec 17th, 2011 via HootSuite
  14. GHTF to morph into Int’l Med Dvc Regulators’ Forum (IMDRF) ht.ly/7ys4o 1:54 PM Nov 18th, 2011 via HootSuite
  15. FDA Extends Comment Period on 510(k) Guidance ht.ly/7slRf 10:19 PM Nov 13th, 2011 via HootSuite
  16. Tracking Vital Signs, Without the Wires ht.ly/7qS0v 12:14 PM Nov 11th, 2011 via HootSuite
  17. Boston Scientific CRV Division Launches iPad App CardioTeach™ ht.ly/7q5iJ 11:30 PM Nov 10th, 2011 via HootSuite
  18. MD&DI Interview Leo Eisner on NB-MED Draft Document EN60601 Implementation for EU ht.ly/6UdPc 12:17 PM Oct 11th, 2011 via HootSuite
  19. Oct 1 2011 DRAFT “FAQ related to Implementation of EN 60601-1:2006 Clarification of open issues” for EU was issued http://ht.ly/6PNVD 1:32 PM Oct 6th, 2011 via HootSuite
  20. EU REACH Report DCG’s Achievements, Lessons Learned & Recommendations issued 20 SEPT 2011 re: 1st REACH register deadline http://ht.ly/6L1I5 2:21 PM Oct 2nd, 2011 via HootSuite