Medical devices regulatory workshops

23rd November 2017 (additional date)
raPHARM premises, 30 Miklošičeva Street, Ljubljana (Slovenian language)

Regulatory workshop on medical devices wholesale HOW TO PRESENT YOUR PROCEDURES AND DOCUMENTS TO PROVE FULFILLMENT OF LEGISLATIVE OBLIGATIONS

  • Fulfillment of legislative obligations with medical devices wholesale
  • Optimal and adequately evidenced medical devices wholesale process
  • Prompt and effective compliance check of medical devices placed on the market
  • Documented establishing and maintaining a medical devices vigilance system
  • Adequately evidenced medical devices advertising activities
  • Adequate evidence of activities in accordance with the legislation required for inspection
  • Quick and efficient integration of new employees into the process

Click HERE for more information.

Click HERE to apply for workshop.

 

30th November 2017 (additional date) – FULLY BOOKED
raPHARM premises, 30 Miklošičeva Street, Ljubljana (Slovenian language)

Regulatory workshop MEDICAL DEVICES VIGILANCE

  • Incidents to be reported to a CA, incidents not to be reported to a CA and incidents that require FSCA and FSN
  • The event, being addressed in line with periodical reporting summaries
  • Changes in trends that need to be reported
  • Method of reporting and notification, deadlines
  • Sequence and content of activities, expectations of the CAs
  • How to properly fill the applicable national and EU forms with adequate and concise data
  • Proper communication with users and CA/NB
  • Communication between the CAs

Click HERE for more information.

Click HERE to apply for workshop.