Course Content
For seasoned professionals in the medical product industry, the landscape has been changing – not only the regulatory side, but in the realities of newer technologies and the capabilities they place within reach for all. This one-hour course will bring you up to date on the most significant regulatory changes of the recent few years (both US and EU), as well as the thinking behind them. Examples include
- SaMD (Software As a Medical Device: software with a medical device function, but running on a general purpose platform, not embedded in a physical device)
- Mobile medical applications
- Security issues
- Risk management
- Human factors
All of the current regulatory requirements can be satisfied through proven Agile practices, and examples of these will be presented.
Learn the thinking behind the regulations, not just a mountain of disconnected alphabet soup. The people at the highest levels in regulatory bodies understand that a well-implemented set of Agile practices supports high-quality better than traditional methods have done. Your course instructors know that Agile is not a panacea; there’s no substitute for good engineering and strong feedback loops.
You will gain clarity on
- the reasoning behind the latest regulatory changes
- questions you have concerning your current project’s regulatory situation
- how others are using Agile practices and tools to simplify compliance
Who Should Attend:
This course is designed for professionals who already have considerable experience (in various roles) delivering software for medical applications of all criticality levels. These attendees would be appropriate:
- Product managers
- Quality Assurance managers
- Software developers
- Engineers (Electronic, Mechanical, and others who will do medical product work)
- Usability professionals
This course will always contain the most current regulatory thinking, so its content will be updated often. Consider attending it every year or two.
Prerequisites:
- Familiarity (through training, reading, or experience) with common Agile practices such as working in sprints, the use of user stories for requirements, and test-driven development.
- At least three years’ experience working on regulated medical products or medical devices
Please note these sessions are only available to Software Cornwall members and any bookings by non-members will be cancelled.
Register Your Interest
Course dates, price and availability will be determined based on volume of interest.
Register Your Interest