Top menu

Software development according to IEC 62304 (2 day course)


Software development according to IEC 62304 (2 day course)

Description

The course is focused on how to develop medical device software and maintaining it according to the requirements of the IEC 62304 standard.

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” instead of requirements only.

Format

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

Recommended pre-requisites

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.

Outline

Day 1 – 09:30-16:30

Intro, regulatory overview

SW Lifecycle introduction and background

Requirements management

Risk management

Q&A

Day 2 – 09:00-16:00

Risk management cont.

Code level Quality assurance

Efficient testing

Software maintenance

Workshops

Knowledge test

Q&A

Instructor

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.

Registration

This link will take you to the registration page!