Medical device software regulations in the EU

1-day Webinar

There are significant changes in the EU regulations regarding medical device software. This training represents our current knowhow with a future perspective.

Aim of the training day
To update you on the status of the regulatory requirements on medical device software according to MDR 2017/745 and IVDR 2017/746. To convey the best ways how to utilize the core medical device software-related standards IEC 62304 and IEC 82304-1 in practice for compliance in the EU. To improve the understanding of medical device software risk management (including an update on the latest cybersecurity standards) and clinical evaluation of medical device software. The training covers software as part of a medical device and software that are devices in themselves (SW as a medical device).

Topics

  • Medical device software regulatory update according to EU MDR 2017/745 and EU IVDR 2017/746
  • Core standards IEC 62304 and IEC 82304-1 and how to make them work for you
  • Risk management for medical device software, including an update on the latest cybersecurity standards, IEC 81001-5-1
    and IEC 60601-4-5
  • Clinical evaluation of medical device software

Target group
This training is intended for anyone working with software which is, or may become, classified as a medical device. This includes for example software engineers and quality & regulatory professionals working at medical device companies, research units or healthcare units developing medical software and digital health products or services.

Presentations
This webinar will be held in English.
Digital presentation material will be sent to you afterwards.

Location
The training will be administrated as a Zoom webinar.
Detailed information for how to attend, will be sent to you in the confirmation email.

Course Leaders
Robert Ginsberg, Chairman of the board, Principal consultant
Mikael DahlkePrincipal consultant
Cecilia EmanuelssonPrincipal consultant

Dates and location

Lund
To be decided / On request

Stockholm
To be decided / On request

Online webinar
To be decided / On request

Price
3 800 SEK
(excl. local VAT)

For group registrations, the 2nd and 3rd persons from the same company will receive a 10% discount. For 4th and additional persons, a 20% discount will be applied.

Customized training courses and seminars

We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.

Registration QAdvis Academy

This course is arranged by QAdvis Academy. Use the contact form below for your reservation.

Questions: email QAdvis Academy or call +46-(0)8-621 01 05.

NOTE! The registration will be valid upon returned confirmation by QAdvis.

An invoice (pdf) will be sent to your email address.

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Terms
Cancellations must always be communicated to Academy@qadvis.com and confirmed by us. Cancellations made more than 4 weeks before the starting date are free of charge. Cancellations made 4–2 weeks before the starting date of the event will be refunded by 50%. Cancellations made less than 2 weeks before the starting date of an event will not be refunded. If you are unable to attend, substitution with a colleague is possible and recommended.

QAdvis reserves the right to cancel the course due to low attendance, up until 2 weeks before the course start. You can contact us at any time to get a status update. If the course is cancelled, a full course fee refund will be offered, but no additional reimbursements. We reserve the right to change the agenda, time and location, up until 2 weeks before the course.

Force majeure
QAdvis reserves the right to change teachers or reschedule the course due to force majeure or due to teacher’s illness. No compensation will be paid for any additional costs incurred.