Hello All Attendees of the Nov. 8, 2018 Chicago RAPS Chapter Event,
As promised a Community Site was created for all attendees of the Nov. 8, 2018 event. All presentation information and reference documents have been uploaded to this community site.
1) MDR Technical Documentation Requirements
2) MDR Updates
3) Classifications
4) RAPS Post Market Surveillance
5) Unofficial Device Classifications and Rules
6) PIP Background
7) Medical Device Recalls
The community site is available to all that attended the November 8, 2018.
Please let me know if you have any questions.
Thank you again for attending.
Sincerely,
Joe Orlowski
PS The Next Events are:
1) a FAST 30 minute Volunteer Teleconference Call on Nov 19, 2018
2) a FAST 30 minute Volunteer Teleconference Call on Dec . 12, 2018
3) a FAST 30 minute Volunteer Teleconference Call on Jan. 16, 2019
4) a Chapter Event on Jan 24, 2019 - FDA Pre-submission Process
5) a FAST 30 minute Volunteer Teleconference Call on Feb. 20, 2018
6) a Chapter Event on Feb. 21, 2019 -Companion Diagnostic and IVDR
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Joseph Orlowski RAC
Associate Director Global Regulatory Affairs
North Chicago IL
United States
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