[Webinar]: Key aspects of EU regulation regarding the medical devices by GS1 and SoftGroup

Description

 

The deadline for the introduction of serialization for medical devices and in vitro diagnostic devices is approaching. However, their implementation raises certain questions and challenges for manufacturers, importers, and authorized distributors.

We are pleased to invite you to an online training seminar to introduce you to the upcoming regulations and answer your questions.

 

Date:  5  October 2020, 9:30 to 13:30 

 

Working language: Bulgarian

 

Key topics

 

  • Medical Devices Regulation (MDR) (2017/745/EU)
  • In Vitro Medical Device Regulation (IVDR) (2017/746/EU)
  • UDI Carriers – Barcode Format & Human-readable information
  • Medical Devices & In Vitro Devices classifications & implementation dates
  • European database on medical devices (EUDAMED) – overview, timelines, modules, and registration
  • Differences in requirements EU MDR vs US FDA

 

Lecturers

 

GS1 Bulgaria

GS1 is an international not-for-profit association with Member Organisations in over 112 countries. GS1 is dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. The GS1 system of standards is the most widely used supply chain standards system in the world.

 

SoftGroup

SoftGroup is a software company that provides all-in-one traceability technology to the pharmaceutical industry worldwide. In our 16 years of experience, we are recognized as a reliable serialization and aggregation solution provider from Big Pharma Leaders with many production lines to small Marketing Authorization Holders (MAHs) with no real production.

 

Registration

 

The regular participation fee is BGN 190 per person including VAT, paid by Bank transfer.

Registrations are considered in the order of receipt. After receipt of your registration, you will receive a confirmation and the proforma invoice. The proforma invoice will be issued after filling the official registration form.

 

Link to the registration form HERE

 

 

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