The course is focused on how to develop medical device software and maintaining it according to the requirements of the IEC 62304 standard.
• 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” instead of requirements only.
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. Useful templates are included in the course. The standard is not included in the course.
Who should attend?
Instruction is targeted towards professionals who are involved in the following areas:
– the development of medical devices in general and of software in particular
– quality assurance
There are no pre-requisites but it is helpful to have experience with product and software development in medical device industry. Link to some introductory video material on design control and risk management will be emailed to course participants upon registration.
Day 1 – 09:30-16:30
Intro, regulatory overview
SW Lifecycle introduction and background
Day 2 – 09:00-16:00
Risk management cont.
Code level Quality assurance
Robert Ginsberg has 25+ years of experience in software development, and the entire chain for product development, Agile, Lean and quality assurance in Medtech environments. He has implemented modern software techniques and methods at several companies. He is often engaged to conduct product and software risk analyses, improve the way of working and finding efficient levels of compliance.
Robert holds an MSc in Technical Physics from Uppsala University and is Certified Lead Auditor (ISO 13485 and QSR). He is a member of the Swedish national standardization committee for IEC 62304 and related standards.
Dates and place
The course will be on the 14-15th of March in Malmö at Radisson Blu, Malmö.