This course provides a general overview of current standards within cybersecurity for medical devices, and an overview of the cybersecurity requirements in the IVDR and MDR.
- Background – what sets medical devices apart?
- Requirements in the IVDR and MDR.
- The cybersecurity standards landscape.
- The new process lifecycle standard.
- The new technical report with product requirements.
- Introduction to FDA requirements and drafts.
- Introduction to ISO 27000.
Regulatory affairs managers, quality managers, development managers and senior software developers and IT managers who need to create a structured system for cybersecurity product risk management.
After the course, participants will have a general understanding of cybersecurity risk management with regards to development process, product and organization according to the latest international standards and of the requirements in new European regulations, such as the IVDR and MDR. Participants will also have an understanding of where the ISO 27000 standards fit in.
Recommended prior knowledge
A basic knowledge of risk management according to ISO 14971.
A basic knowledge of IT security.
Course material will be in English, verbal presentation and discussions varies between Swedish and English. The information can be found beside the course date.
Nils Lidström, Senior Quality and Regulatory Consultant
Krishnadev Moothandassery Ramdevan, Quality and Regulatory Consultant
Dates and location
2 and 3 May, (English)
Our 1-day course divided
into two half day/sessions.
08.30-12.30 both days.
SEK 8 600:-
All prices excl. local VAT.
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.
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.