2018 Summer Educational Meeting Materials

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- 2018-07-23 at 7:27 pm #3470
  pronto test
  Keymaster
  
  Strategic Partner, Individual, MCRA
  Attached documents include:
  
  2018 OSMA Summer Educational Program Minutes
  - Attachment 1 – 2018 OSMA Summer Educational Presentation (morning)
  - Attachment 2 – 2018 OSMA Summer Educational Presentation (afternoon)
  - Attachment 3 – Attendee List
  Guest Presentations
  - Brexit Update (Phil Brown, ABHI)
  - MEDEC RA Update: Key Priorities, Issues and Opportunities to Partner (Diana Johsnon, MEDEC)
  - Medical Devices Bureau: Key Initiatives/Priorities, Aspects of R2D2, Cost Recovery (David Boudreau, Health Canada)
  - Health Canada Update: MDSAP (Frederic Hamelin, Health Canada)
  - Health Canada Update: Investigational Testing Authorization (Chris Schmidt, Health Canada)
  - Clinical Data Transparency (Sally Prawdzik, Johnson & Johnson)
  - IMDRF and TOC Update (Sally Prawdzik, Johnson & Johnson)
  Additional Documents:
  - Health Canada Info Bulletin July 2018
  ATTACHMENTS
  - This topic was modified 3 years ago by Saa Kosiri.
  - This topic was modified 3 years ago by Saa Kosiri.
  - This topic was modified 2 years, 12 months ago by Saa Kosiri. Reason: Migration
  - This topic was modified 2 years, 8 months ago by pronto test.
- 2018-07-23 at 11:39 pm #4951
  
  pronto test
  Keymaster
  
  Strategic Partner, Individual, MCRA
  
  Re: new notified body numbers under re-designation to EU MDR
  
  Doing a little around the box thinking and it looks like NBs were redesignated from 89/686/EEC Personal protective equipment to Regulation (EU) 2016/425 Personal protective equipment, but kept their same number. So, there may be precedent for not changing the numbers. The PPE looks to be mostly self-certified, but in the case of Class III equipment the NB is utilized and the CE Marking contains the number.
- 2018-08-08 at 8:54 pm #4950
  
  pronto test
  Keymaster
  
  Strategic Partner, Individual, MCRA
  
  Thanks Gregg. ABHI came back with a revised response to their statement. Please refer to the updated meeting minutes.
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