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

Practical information

NOTE: 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.

  • 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)
  • Minimum number of booked places needed at 7.5.2019: 20
  • Maximum number of places: 30 (ask if any places free)
  • USBIMED reserves the right to reschedule or cancel the course due to force majeure or due to teacher’s illness. Event might be cancelled also if number of attendees registred at 7.5.2019 is less than 20 (passed). No compensation will be paid for any additional costs. Payment will be billed after the event.

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 attendee from your organization.
  • Registration by 7.5.2019 required. (Registration is over. Ask about possible free places by e-mail)
  • Cancellation by 7.5.2019 at latest, free of charge
  • Cancellation during 8.5. - 23.5.2019 payment 50 %. Substituting colleague may be announced.
  • Cancellation 24.5.2019 or later – full payment. Substituting colleague may be announced.

Target group

Prioritized especially for medical device product companies and also for research projects and actors of healthcare units developing 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.

Aim of 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, 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 at conference room
  • 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 2017/745
  • 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 Risk management for medical software. Agile development.
  • 14:30-14:45 Afternoon coffee at conference room
  • 14:45-16:15 Current topics discussion - including artificial intelligence, cybersecurity, cloud based services
  • 16:15-16.30 Take Aways

More information

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

Since the founding of USBIMED in 2011 company has completed several expert projects, as well as organized and prepared numerous public and private training packages and presentations. Company wants to contribute to the advancement of the health technology and digital health communities.

Created By
Terhi Holappa

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