Introduction to 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

Learning in the school of hard knocks is expensive and risky.  This one-hour course will teach you the concepts that professionals moving to regulated medical product work wish they knew right from the start. The focus is on two key areas: helping you build the foundations you need to understand so that the myriad rules, advisories, and standards all make sense; and also on how the regulatory framework fits nicely to Agile practices.

Using crisp examples and brief interactive exercises, you will come away knowing how your type of product fits into the regulatory scheme – things like

  • safety risk and how to rank it
  • who is the responsible party for holding regulatory certifications
  • what quality process needs to have in order to get your product to market

You will come away knowing what the regulatory compliance roadmap looks like, where you now stand, and the next learning paths that are open to you. [US and/ or EU regulatory info is covered, based on needs of the attendees.]

Who Should Attend:

This course is ideal for professionals with some experience (in various roles) delivering software for non-medical applications. 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


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. 

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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