NOTE: This training day was arranged in co-operation with USBIMED and QAdvis AB at May 2018 and June 2019. 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: Wednesday 24.3.2021, 9:00-16:30
- Practical organizer, host: USBIMED (Terhi Holappa)
- Instructor: QAdvis AB, Stockholm, Sweden (Robert Ginsberg, Mikael Dahlke, Cecilia Emanuelsson)
- Mode: Webinar (Teams -link will be sent one week before the event)
- Registration by 24.2.2021. Official registration now closed, ask Terhi Holappa for possible free places.
- Targeted for organizations and experts in Finland
- 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 24.2.2021 is less than 20. Payment will be billed after the event.
Registration and cancellation policy
- Fee: 390 € (alv 0%) per participant. VAT 24 % will be added to price. The fee includes: training and course materials.
- Cancellation by 24.2.2021 at latest, free of charge
- Cancellation during 25.2. - 10.3.2021 payment 50 %. Substituting colleague may be announced.
- Cancellation 11.3.2021 or later – full payment. Substituting colleague may be announced.
Prioritized especially for Finnish medical device product companies, research projects and healthcare units developing medical software and digital health products or services. 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 device SW according to MDR 2017/745. To learn the best ways how to utilize core medical device software related standards IEC 62304 and IEC 82304-1 in practice for compliance (EU). To deepen the understanding of medical device software risk management (including cybersecurity) and clinical evaluation of medical device software. Training covers software as part of medical device and software that are devices in themselves (sw as medical device).
- Course instructor Robert Ginsberg, Chairman of the board
- 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 belongs also to the EU SW workgroup.
- Course instructor Mikael Dahlke, Principal quality and regulatory consultant
- Bio: Mikael Dahlke has more than 25 years experience from development of medical devices and extensive experience from risk management. He is a an active member of the standardization: Swedish mirror committee of TC62 (60601 and others), Swedish expert in the IEC 62304 project team., Swedish expert in the new cybersecurity standards IEC 81001-5-1 and 60601-4-5.
- Course instructor Cecilia Emanuelsson, Principal consultant
- Bio: Cecilia Emanuelsson has extensive experience from the medical device industry as well as from academic research. She has specific expertise in the assessment of clinical evidence for medical devices. Cecilia Emanuelsson holds a PhD and an MScPharm from Uppsala University, where she is also appointed associated professor.
Program of the day
- 8:30-9:00 Joining to webinar, host Terhi Holappa
- 9:00-9:05 Welcoming words and practical info by Terhi Holappa, USBIMED
- 9:05-10:30 Medical device software regulatory update according to EU MDR 2017/745, Robert Ginsberg QAdvis AB
- 10:30-10:40 Short break / Coffee pick-up
- 10:40-12:15 Core standards IEC 62304 and IEC 82304-1 and how to make them work ?, Robert Ginsberg QAdvis AB
- 12:15-13:00 Lunch break
- 13:00-14:30 Risk management for medical device software, including cybersecurity, Mikael Dahlke, QAdvis AB
- 14:30-14:45 Coffee break
- 14:45-16:15 Clinical evaluation of medical device software, Cecilia Emanuelsson QAdvis AB
- 16:15-16.30 Take aways and final discussion
Terhi Holappa, +358 40 5595726, firstname.lastname@example.org
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.