Medical Software Regulation and Compliance (EU MDR 2017/745) practice and current topics

This training day was first arranged in co-operation with USBIMED and QAdvis AB at May 2018. As a response to requests this succesfull training day will be arranged again since a lot is happening at the moment, what comes to regulations and software at EU and also globally. Content is updated and represents current knowhow with future perspective also.

AIM OF THE TRAINING DAY

To update the status of the regulatory requirements of medical SW according to MDR 2017/745. To learn about best ways how to utilize IEC 62304 and IEC 82304-1 in practice for compliance (EU). To deepen the understanding of medical software risk management. Training covers software incorporated in device (medical device SW) and software that are devices in themselves (SW as medical device). During the training day special current topics are discussed – like artificial intelligence and cybersecurity.

REGISTRATION by 7.5.2019
Minimum number of booked places needed at 7.5.2019: 20
Maximum number of places: 30
Registration and info: https://spark.adobe.com/page/c7yecNxBoLRSP/

INSTRUCTOR: Robert Ginsberg, QAdvis AB
Bio: Robert has 30+ years of experience of software development, and the entire chain for product development, Agile, Lean and quality assurance in Medtech environments. He has implemented modern software techniques and methods at several companies.

TARGET GROUP

Prioritized especially for medical device product companies and also for research projects and actors of healthcare units working with medical software and digital health products. This training day is also suitable to all software or regulatory affairs professionals in general who work with theme in practice or are leading these activities.

  • Date and time: Thursday 6.6.2019, 8:30-16:30
  • Venue: Tapahtumatalo Bank, Helsinki
  • Practical organizer: USBIMED (Terhi Holappa)
  • Instructor: QAdvis AB, Stockholm, Sweden (Robert Ginsberg)
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Date

Jun 06 2019

Time

8:30 am - 4:30 pm

Local Time

  • Timezone: America/New_York
  • Date: Jun 06 2019
  • Time: 01:30 - 09:30

Cost

450 € (405 € for Upgraded members)

More Info

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Location

Helsinki
Helsinki
Category

One response to “Medical Software Regulation and Compliance (EU MDR 2017/745) practice and current topics”

  1. Greetings! Very helpful advice within this article! It is the
    little changes that will make the most significant changes.

    Many thanks for sharing!

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