This course focuses on how to design a process for the development and maintenance of medical device software according to the IEC 62304 standard and the regulatory requirements that apply to medical device software.
- Current software practices
- Designing high quality software in a regulated environment
- Standards for regulatory compliance
- Implementation examples for achieving compliance
- Practical applications of the requirements of the 62304 standard
- Some possible future changes within the medical device software field
This course is targeted towards professionals working with the development of medical devices containing software or software as a medical device (SaMD), with risk assessment of software-based products, quality assurance, process improvements, with the purchasing of software development from subcontractors, or purchasing software components.
After the course, participants will have an understanding of how to employ design processes for medical device development based on the 62304 standard, in order to achieve regulatory compliance and how to design high quality software in a regulated environment.
Recommended prior knowledge
A basic understanding of the medical device regulations (for example https://en.wikipedia.org/wiki/Medical_device) and some product and software development experience is recommended.
Course material will be in English, verbal presentation and discussions in Swedish or in English, depending on the participants.
Robert Ginsberg, Chairman of the board, Principal Consultant
Dates and location
17 and 19 February
09:00 – 16:00, both days
Onsite: SEK 14 300:-
Online: SEK 13 600:-
Price in package*
All prices excl. local VAT (moms).
*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.