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Medical Software Regulation and Compliance (EU) practice and current topics

Practical information

  • Date and time: Thursday 24.5.2018, 8:30-16:30
  • Venue: Tapahtumatalo Bank, Helsinki
  • Practical organizer: USBIMED (Terhi Holappa)
  • Instructor: QAdvis AB, Stockholm, Sweden (Robert Ginsberg)

Registration and cancellation policy

  • Fee: 450 € (alv 0%) per participant. VAT 24 % will be added to price. The fee includes: training, course materials, lunch and both coffee breaks. Ask for discount if more than one participant from the same organization.
  • Registration by 24.4.2018 required (original dead-line)
  • Cancellation should be made by 24.4.2018 at latest
  • Cancellation at 25.4.2018 or later, 50 %
  • No show – full payment

NOTE 14.5.2018: Registration to the event has now ended. Please ask straight from the organizer wheather there is some places free due to cancellation.

Target group

Prioritized especially for medical device industry (manufacturer, "product company"). Also for medical device and digital health R&D projects (like "Tutli") . 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.

Aim of training day

To update the status of the regulatory requirements of medical SW according to MDR/745. To learn about best ways how to utilize IEC 62304 and IEC 82304-1 in practice for compliance (EU). 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 topics are discussed – like agile development and risk management of medical software, cloud based services and cybersecurity.

Program of the day

  • Course 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. He is often engaged to conduct product and software risk analyses, improve way of working and find and efficient level of compliance. Robert holds an MSc in Technical Physics from Uppsala University, is Certified Lead Auditor (ISO 13485 and QSR), and is a Swedish expert for international standardization group for IEC 62304 and related standards. He is also in EU SW workgroup.
  • 8:30-9:00 Registration and morning coffee
  • 9:00-9:05 Welcoming words and practical info by Terhi Holappa, USBIMED
  • 9:05-10:30 Medical software regulatory update according to EU MDR/745
  • 10:30-10:40 Short break (stand-up for a while, bio-pause)
  • 10:40-12:15 How to make IEC 62304 and IEC 82304-1 work ?
  • 12:15-13:00 Lunch buffee at restaurant
  • 13:00-14:30 Agile development and risk management for medical software
  • 14:30-14:45 Afternoon coffee at conference room
  • 14:45-16:15 Current topics - cybersecurity and cloud services
  • 16:15-16.30 Discussion / QA

More information

Terhi Holappa, +358 40 5595726, terhi.holappa@usbimed.fi

Created By
Terhi Holappa
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