Assurance cases for medical devices

Safety assurance cases are required by the FDA as part of pre-market submissions for new infusion pumps. Adelard offers a two-day training course on the development of safety assurance cases, covering the fundamental concepts, theory and best practices, whilst focusing on meeting FDA requirements. We are also offering an optional third-day training course on ASCE software tool dedicated specifically to professionals working in the medical devices sector. ASCE software is the leading commercial system for the development and management of assurance cases and is widely used by medical devices manufacturers.

Who should attend the training?

  • Experts in quality assurance, regulatory affairs and engineering can attend the training course. We recommend that a combination of staff from these areas participate, as these will all be providing input to the assurance case.

Locations

  • Currently the training course is provided remotely to enable flexibility of learning at your chosen location.

Customised and Private Courses

We are available to organise other training courses adapted to your needs: different time zones, dates, number of modules taken on a day. For larger groups, we can provide a private training course dedicated to your team’s needs.

Course objectives

The aim of the course is to enable safety participants to:

  • Understand the theoretical and methodological concepts of assurance cases
  • Apply these concepts towards meeting FDA requirements
  • Understand the technical and project challenges associated with developing an assurance case (and an assurance case report)
  • Address cyber-security within the safety assurance case

Fees & registration

  • Assurance cases for medical devices two-day course - £1,500 + VAT
  • Assurance cases for medical devices three-day course - £2,000 + VAT

Please contact us to learn more about the training.