Welcome to join our weekly Medical Device webinars

2020-05-19 20:25

Webinars take place every Thursday at 14:00 – 15:00 (EEST) starting from 28th May until 18th June 2020.

Why to Join?
The purpose of this webinar series is to give oversight of the updated medical device regulation, including the latest updates.

To Whom?
This series is intended for organizations involved with medical devices (sales and marketing, importer, distributor, manufacturer).

Reserve Your Spot Now! Choose ANY WEBINAR from the list below.

The special price for you is only 50 € (+24% VAT) per webinar.


REGISTER HERE! Link – MD Webinar sessions

Registration no later than the day before each actual webinar.
You will receive the participant link on the actual webinar day.

CE marking – What do I need to know? 28.5.2020 at 14:00 – 15:00 (GMT+3) / Price 50 € (+ 24%)

  • importing products from outside EU
  • distributing products manufactured in EU
  • need for additional labeling – localization of the product


Speaker: Jonas Hinkkanen, Head of Regulatory Affairs, Biocodex Oy



Building Quality Management system for Medical Devices 4.6.2020 at 14:00 – 15:00 (GMT+3) / Price 50 €  

  • QMS for Distributor
  • QMS for Manufacturer
  • QMS for Importer and EU authorized representative



Speaker: Jonas Hinkkanen, Head of Regulatory Affairs, Biocodex Oy


How to perform clinical overview? 11.6.2020 at 14:00 – 15:00 (GMT+3) / Price 50 € (+24% VAT)

  • Clinical evaluation plan
  • Clinical evaluation report
  • Clinical evaluation follow-up
  • Claims about devices performance – basis of marketing compliance



Speaker: Jenni Kononoff, Head of Medical Affairs, Biocodex Oy



Proactive Post-Market surveillance 18.6.2020 at 14:00 – 15:00 (GMT+3) / Price 50 € (+24% VAT)

  • Post-Market Surveillance System
  • Active role in Post-Market surveillance
    • complaints
    • vigilance


Speaker: Susanna Heinonen, Head of Pharmacovigilance, Biocodex Oy




If you have any questions regarding the webinars, please contact PhaMe assistant Tea Kovanen t.kovanen@biocodex.fi