This course provides a general overview of risk management according to TIR-57, focusing on the documentation that authorities require manufacturers to create and maintain in order to prove that they have used a structured process for managing all kinds of risk management.
- Background – what sets medical devices apart?
- The AAMI TIR-57 technical information report
- FDA guideline documents
- European regulations and directives; MDR and NIS
- The new IEC and ISO standardization
- The ISO 27000 standards
- The risk management process
- Important concepts
- The risk management toolbox
- Risk analysis
Regulatory affairs managers, development managers and IT managers who need to create a structured system for cybersecurity risk management.
After the course, participants will have a general understanding of risk management according to TIR-57. and of the new European regulations and directives, such as the MDR and NIS, which require cybersecurity risk management. Participants will also have an understanding of the ISO 27000 standards.
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.
Robert Ginsberg, Chairman of the board, Principal Consultant
Mikael Dahlke, Principal Consultant
Dates and location
Our one day course divided in to two half-day sessions
1 och 2 september (English)
13.00 – 16.30
Online: SEK 6 900:-
Onsite: SEK 7 800:-
All prices 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.
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.
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.