FREE Webinar on 14th May 2020 – Medical Devices and upcoming new regulations

2020-05-05 14:19

Medical Devices and upcoming new regulations on Thursday 14.5.2020 at 14:00 – 15:00 (GMT+3)

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).

First webinar FREE of charge!
Topic: Regulation MDR 2017/745

  • What changes
  • What is the timetable
  • What is your role and responsibility?

Petra Lehtinen

 

 

 

Speaker: Petra Lehtinen, Senior Regulatory Affairs and Quality Management Specialist, Biocodex Oy

 

Reserve Your Spot Now!
Click the link to register for the FREE Webinar Regulation-MDR—Webinar-14.5.2020

Registration is open until Tuesday 12.5.2020

You will receive the participant link on the actual webinar day.

 

Join us and hear our experts presenting current topics also in upcoming webinars seen below!

Register for the upcoming webinars by sending email to info@biocodex.fi

 

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

Speakers: Jonas Hinkkanen, Head of Regulatory Affairs, Biocodex Oy
Petra Lehtinen, Senior Regulatory Affairs and Quality Management Specialist, Biocodex Oy

>> 

Building Quality Management system for Medical Devices 4.6.2020 at 14:00 – 15:00 (GMT+3) / Price 50 € (+24% VAT)

  • 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

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