Software as Medical Device and Quality Management
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.
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
Trainer
Brian Hedegaard, CEO, Probatus
What previous participants said
Contact
Select date
15-16.06.202615-16 June 2026 - at 09:00 - 16:50
Price ex. VATLatest Registration
09.06.2026
Latest Cancellation
25.05.2026
Bøge Allé 5, 2. th
2970 Hørsholm
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Terms
In-house Courses
MedTech Academy offers in-house training courses tailored to your specific needs. Courses can be based on our open programme or developed specifically for your organisation. You choose the focus, format and timing – and work with your own cases in a confidential setting. Contact us to discuss the possibilities.
Do You Have a Specific Competency Need?
We continuously develop and update MedTech Academy’s course portfolio to match the current needs of medical device companies. If you are looking for a specific course, or if you are unsure which course is the right fit for you and your organisation, you are always welcome to contact us.
Berit Munkebo
Head of Development
bm@medicoindustrien.dk
Academy News
Academy News is Medicoindustrien’s weekly newsletter with a complete overview of upcoming and newly developed courses from MedTech Academy. The newsletter provides a quick overview of new dates, upcoming sessions and current course topics for professionals working with medical devices.