This two-day course covers design control principles, and design and development regulatory requirements according to the US 21 CFR Part 820, ISO 13485:2016 and the EU MDR. Practical examples will be incorporated. The course covers important requirements for medical device and IVD design controls. Learners will benefit from open dialogue and the sharing of current design and development processes; highlighting how misperceptions of regulatory requirements have led to less-than-optimal practices. This course also provides guidance for all phases of medical device design and development projects, as well as retrospective gap analysis of design history files to help develop new technical files under the EU MDR and IVDR.

Organiser: NSF

Location: Virtual

Contact: https://www.nsf.org/training/series/design-controls-for-medical-devices-and-ivds-training