Course objective and outcome
The course introduces regulatory requirements that are particularly affecting software as medical device and how they can be addressed effectively, also in an agile development model and when developing Artificial Intelligence solutions.
Gain knowledge about how to classify and qualify your digital health solutions/medical device software and how to evaluate the technical documentation.
 
The course is focused on the practical implementation of quality procedures for development of software as medical device (SaMD) and medical device software (MDSW) when having inhouse development or having outsourced the software development activities.
 
The course is designed to provide you with a pragmatic and practical approach to establish and maintain quality oversight for software as medical device. Key standards will be introduced, but the standards will not be covered in detail.
 
Software, whether stand-alone or embedded is a specialized discipline, just as any other discipline involved in the development of medical devices. Software however is very flexible and rapid changes do occur that tends to challenge quality oversight and maintaining compliance throughout the product lifecycle.
 
Content
 
The learning objectives of the course are to:
 

• Clarify when digital health solutions qualify as medical device and the device classification
• Provide insight and practical knowledge on design and implementation of procedures and tools for the quality management activities for software development to boost the ability to be efficient in the development of medical device software and the related documentation
• Improve understanding of the importance of design control
• Increase knowledge on interactions of processes, managing documentation and traceability to ensure compliance and quality assurance
• Understand the key requirements of ISO 13485:2016 on software development and the interactions of IEC 62304 on software lifecycle, ISO 14971:2020 on risk management, IEC 82304-1 on general safety for software and interaction with IEC 62366-1 on usability
• Gain knowledge about selection, qualification and validation of tools used in software development

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

• Development of medical device software and software as medical device
• Quality Assurance of software development activities and deliverables
• Project Managers within the medical device area

There are no pre-requisites, however, it is helpful to have experience with software development or quality management in product development from the medical device industry or any other regulated industry.
 
Trainer
Brian Hedegaard, CEO, Probatus

"The content of the course was a good fit with my need and the speaker was interesting and a good presenter"

"Liked the explanations about the extra requirements and challenges dealing with cybersecurity and the use of Artificial Intelligence"

"Instructor was very approachable, and seemed knowledgeable on a wide variety of related subjects. Good slides. Interesting subject that was well covered"

"Really good to get an overall overview of software development / how to think cybersecurity and AI aspects in the development and also the QMS technical documentation"

Participants, Spring 2023