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).
- 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
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.
This webinar will be held in English.
Digital presentation material will be sent to you afterwards.
The training will be administrated as a Zoom webinar.
Detailed information for how to attend, will be sent to you in the confirmation email.
QAdvis AB, Stockholm, Sweden.
Robert Ginsberg, Mikael Dahlke, Cecilia Emanuelsson
Training instructor Robert Ginsberg, Chairman of the board, Principal consultant
Bio: Robert has 30+ years of experience of software development, and the entire chain for product development (especially Agile and Lean) and quality assurance in Medtech environments. He has spearheaded implementation of modern software techniques and methods at several companies, small and large. He is often engaged to conduct product and software risk analyses, process improvements to find an efficient level of compliance. Robert holds an MSc in Technical Physics from Uppsala University, and is a Swedish expert in the international standardization group for IEC 62304, IEC 82304-1 and other related standards. He is active participant in the EU MDCG workgroup for software.
Training instructor Mikael Dahlke, Principal consultant
Bio: Mikael Dahlke has more than 25 years experience from development of medical devices and extensive experience from risk management. He is an active member of the standardization: Swedish mirror committee of TC62 (IEC 60601-1 and others), Swedish expert in the IEC 62304 project team., Swedish expert in the new cybersecurity standards IEC 81001-5-1 and IEC 60601-4-5.
Training instructor Cecilia Emanuelsson, Principal consultant
Bio: Cecilia Emanuelsson has 30 years of 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 MSc Pharm from Uppsala University, where she is also appointed associated professor.
Cancellations must always be communicated to firstname.lastname@example.org 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 webinar 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 software platform, up until 2 weeks before the course.
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.
We are longtime trusted providers of MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Offering a thorough knowledge and understanding of the industry, based on 30 years of professional experience, QAdvis have the tools to help take your MedTech innovations to domestic and international markets.