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.

Topics

• 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

Target group
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.

Educational goals
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 presentations
Course material will be in English, verbal presentation and discussions in Swedish or in English, depending on the participants.

Course leader
Nils Lidström, Senior Quality and Regulatory Consultant.