Who it’s for
Who should attend
Software developers and architects, software verification and validation engineers, software quality staff, regulatory affairs, and project managers responsible for embedded software or Software as a Medical Device.
Curriculum
Course modules
- Scope of IEC 62304 and its relationship with ISO 13485, ISO 14971 and IEC 62366-1
- Software safety classification A, B and C, and segregation of software items
- Software development planning
- Software requirements analysis
- Software architectural design
- Software detailed design
- Software unit implementation and verification
- Software integration and integration testing
- Software system testing
- Software release
- Software maintenance process
- Software risk management process
- Software configuration management process
- Software problem resolution process
- SOUP: identification, evaluation and ongoing monitoring
- Documentation expected per safety class
Outcomes
What you’ll be able to do
- Assign and justify a software safety classification
- Produce the lifecycle documentation required for each class
- Manage SOUP and legacy software in a compliant way
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Software Life Cycle Validation”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.