What’s New in Regulated Medical Software Development - Brian Shoemaker & Nancy Van Schooenderwoert - Software Cornwall

Course Details




Location: Online via Zoom
Times: 14:00 to 15:00
Full Price: £75 +vat

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.


  • 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.

European Social Fund

The European Social Fund is partially funding Software Cornwall to run this training project to provide development training for employees within the software industry. As a Software Cornwall member you will be receiving a discount to this course by email. This course is only available to those from the UK or EU. To participate in the training certain personal information will be required from attendants as proof of employment and eligibility to attend. This information is for the purposes of ensuring that the training will go to the correct participants. You will also be required to complete an evaluation form after the training as part of the attendance.

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