Our services include:
• Quality management support
• System development
• Clinical evaluation
• Medical device software specialist services
• Regulated software validation
• Quality and regulatory consulting
• Training
• European Authorized Representation

2-day Course, 27-28 February in Malmö

Medical device software process design

based on IEC 62304

The course is focused on how to design a process for development and maintenance of medical device software and maintaining it according to the requirements of the IEC 62304 standard and regulatory requirements for medical device software in EU (MDR and IVDR) and USA.

Learning goals
• To give hands-on understanding of current software practices and standards for compliance with regulatory demands
• To give examples of efficient implementation of requirements to achieve compliance
• To provide hints about future changes in the medical device software area

The focus of the course will be practical application of the requirements of the 62304 and ”how-to” make high quality software in a regulated enviroment.

The course comprises lectures, Q&A and workshops at the end of course and a knowledge test at the end. Course material will be distributed digitally and on paper.

The standard is not included in the course, but will be provided during the sessions.

Course material in English, lectures in English (or Swedish if Swedish participants only).

Who should attend?
Instruction is targeted towards professionals who are involved in the following areas:

– the development of medical devices containing software, and software as a medical device (SaMD)
– risk assessment of software based products
– quality assurance
– process improvements
– purchasing software development from subcontractors
– purchasing software Components, OTS

Recommended pre-requisites
Basic understanding of the medical device regulations (for example https://en.wikipedia.org/wiki/Medical_device), and it is helpful to have experience with product and software development.

Date and location
Malmö: 27th and 28th February 2020.
Location: Malmö, Radisson Blu
Time: Day 1 – 09:30– 16:30. Registration and coffee from 09.15.
Day 2 – 09:00-16:00.

Course leader

Robert Ginsberg, Principal Consultant and Chairman of the board
More about Robert>>>

Price and registration
Course fee 14 300 SEK, excl. local VAT (moms). Price includes printed course material, short test, training certificate, lunch and coffees.

An invoice will be sent 2 weeks before course date. 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.

Register by e-mail to academy@qadvis.com.

Please specify:
• Name
• E-mail
• Title/position
• Company
• Invoice address
• Any food related allergies

Registration will be valid upon returned confirmation by QAdvis.


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.

Force majeure 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.

If you have any questions or want to get in contact with us, use academy@qadvis.com.